FDA Product Code
FDA Product Code DAA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5510
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K832675 | ANA MICROZYME TEST SYS #1610 | Clinical Sciences, Inc. | 1983-09-12 | Traditional | PDF ↗ |
| K831927 | ANTINUCLEAR ANTIBODY TEST KIT | Breit Laboratories, Inc. | 1983-07-18 | Traditional | PDF ↗ |
| K830005 | IP SPECIFIC G | Diagnostic Reagent Tech. | 1983-06-02 | Traditional | PDF ↗ |
| K822911 | ANAZYME ANA PEROXIDASE TEST SYSTEM | Clinical Sciences, Inc. | 1982-10-22 | Traditional | PDF ↗ |
| K791749 | INDIRECT IMMUNO ENZYME,ANTIGEN,CONTROL | Clinical Sciences, Inc. | 1979-10-17 | Traditional | PDF ↗ |
Product code DAA · Class II · Immunology. Data: openFDA.