FDA Product Code
FDA Product Code JBF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7360
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K201049 | FINDER G6PD | Baebies, Inc. | 2022-09-14 | Traditional | PDF ↗ |
| K161364 | BinaxNOW G6PD Test | Alere Scarborough, Inc. | 2016-06-17 | Special | PDF ↗ |
| K080003 | BINAXNOW G6PD TEST | Binax, Inc. | 2008-10-23 | Traditional | PDF ↗ |
| K024006 | G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE | Pointe Scientific, Inc., | 2003-03-31 | Traditional | PDF ↗ |
| K933934 | GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A | Sigma Diagnostics, Inc. | 1995-06-29 | Traditional | PDF ↗ |
Product code JBF · Class II · Hematology. Data: openFDA.