K821092 is an FDA 510(k) clearance for the GAMMADAB[125]EGE RADIOIMMUNOASSAY IT. This device is classified as a Ige, Antigen, Antiserum, Control (Class II - Special Controls, product code DGC).
Submitted by Clinical Assays, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 22, 1982, 64 days after receiving the submission on April 19, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K821092 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 1982 |
| Decision Date | June 22, 1982 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | DGC — Ige, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |