FDA Product Code
FDA Product Code LTJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.6010
510(k) Clearances — 34 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251630 | Atellica IM Total PSA II (tPSAII) | Siemens Healthcare Diagnostics, Inc. | 2026-01-05 | Traditional | PDF ↗ |
| K162378 | FREND PSA PLUS (reagent cartridge) | Nanoentek USA, Inc. | 2017-05-17 | Traditional | PDF ↗ |
| K124056 | FREND PSA PLUS (REAGENT CARTRIDGE) | Nanoentek, Inc. | 2013-05-29 | Traditional | PDF ↗ |
| K031343 | TPSA FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2003-05-15 | Special | PDF ↗ |
| K022288 | COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM | Bayer Corp. | 2002-12-17 | Traditional | PDF ↗ |
| K022177 | PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Bayer Diagnostics Corp. | 2002-12-17 | Traditional | PDF ↗ |
| K010550 | VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428 | bioMerieux, Inc. | 2001-04-24 | Traditional | PDF ↗ |
| K003963 | DIMENSION PSA FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2001-02-28 | Traditional | PDF ↗ |
| K002376 | ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY | Bayer Corp. | 2000-10-26 | Traditional | PDF ↗ |
| K003094 | FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER | Qualigen, Inc. | 2000-10-25 | Special | PDF ↗ |
| K002313 | COMPLEXED PSA MICROTITER ELISA | Oncogene Science, Inc. | 2000-08-30 | Traditional | PDF ↗ |
| K002121 | TOTAL PSA MICROTITER ELISA | Oncogene Science, Inc. | 2000-08-30 | Traditional | PDF ↗ |
| K994419 | FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM | Qualisys Diagnostics, Inc. | 2000-06-28 | Traditional | PDF ↗ |
| K994221 | BAYER PSA ASSAY | Bayer Corp. | 2000-04-13 | Traditional | PDF ↗ |
| K000566 | MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS | Ortho-Clinical Diagnostics, Inc. | 2000-03-09 | Special | PDF ↗ |
| K990234 | QUALISYS PSA IMMUNOASSAY | Qualisys Diagnostics, Inc. | 1999-07-08 | Traditional | PDF ↗ |
| K984289 | VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK | Ortho-Clinical Diagnostics, Inc. | 1999-03-12 | Traditional | PDF ↗ |
| K982948 | ELECSYS PSA, MODEL # ELECSYS 1010 | Boehringer Mannheim Corp. | 1998-10-27 | Traditional | PDF ↗ |
| K982949 | ELECSYS PSA, MODEL 2010 | Boehringer Mannheim Corp. | 1998-10-27 | Traditional | PDF ↗ |
| K981634 | BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS | Biocircuits Corp. | 1998-10-13 | Traditional | PDF ↗ |
| K981839 | ACS:CENTAUR PSA2 IMMUNOASSAY | Chiron Diagnostics Corp. | 1998-08-12 | Traditional | PDF ↗ |
| K973243 | ACTIVE PSA ELISA (DSL-10-9700) | Diagnostic Systems Laboratories, Inc. | 1998-08-03 | Traditional | PDF ↗ |
| K973244 | ACTIVE PSA IRMA (DSL-9700) | Diagnostic Systems Laboratories, Inc. | 1998-08-03 | Traditional | PDF ↗ |
| K980376 | THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM | Bayer Corp. | 1998-04-23 | Traditional | PDF ↗ |
| K974842 | IMMULITE 2000 3RD GENERATION PSA | Diagnostic Products Corp. | 1998-04-21 | Traditional | PDF ↗ |
| K980716 | ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA) IMMUNOASSAY | Nichols Institute Diagnostics | 1998-04-03 | Traditional | PDF ↗ |
| K974816 | ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229 | Beckman Instruments, Inc. | 1998-02-20 | Traditional | PDF ↗ |
| K974189 | ELECSYS PSA (ON ELECSYS 1010) | Boehringer Mannheim Corp. | 1998-01-06 | Traditional | PDF ↗ |
| K972021 | IMMULITE THIRD GENERATION PSA (LKUPI,LKUP5) | Diagnostic Products Corp. | 1997-10-31 | Traditional | PDF ↗ |
| K973101 | PROSTATE SPECIFIC ANTIGEN METHOD | Dade Chemistry Systems, Inc. | 1997-09-18 | Traditional | PDF ↗ |
| K972095 | IMMULITE 2000 PSA | Diagnostic Products Corp. | 1997-08-22 | Traditional | PDF ↗ |
| K964351 | ELECSYS PSA ASSAY | Boehringer Mannheim Corp. | 1997-07-25 | Traditional | PDF ↗ |
| K964595 | OPUS PSA TEST SYSTEM | Behring Diagnostics, Inc. | 1997-06-24 | Traditional | PDF ↗ |
| K965085 | ENZYMUN-TEST PSA | Boehringer Mannheim Corp. | 1997-03-19 | Traditional | PDF ↗ |
Product code LTJ · Class II · Immunology. Data: openFDA.