FDA Product Code
FDA Product Code IGC — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Pathology
- 21 CFR Citation
- 864.4010
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K955362 | INCSTAR HSV I/II IGG FAST ELISA ASSAY | Incstar Corp. | 1996-07-24 | Traditional | PDF ↗ |
| K955363 | INCSTAR HSZ I/II IGG ELISA ASSAY | Incstar Corp. | 1996-07-24 | Traditional | PDF ↗ |
Product code IGC · Class I · Pathology. Data: openFDA.