K790479 is an FDA 510(k) clearance for the A-GENT IMMUNOGLOBULINE TEST SYSTEM. This device is classified as a Iga, Antigen, Antiserum, Control (Class II - Special Controls, product code CZP).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on April 3, 1979, 26 days after receiving the submission on March 8, 1979.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K790479 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 1979 |
| Decision Date | April 03, 1979 |
| Days to Decision | 26 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CZP — Iga, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |