K842969 is an FDA 510(k) clearance for the ALLERGENETICS ALLER-SPECIFIC IGE SERUM. This device is classified as a Ige, Fitc, Antigen, Antiserum, Control (Class II - Special Controls, product code DGP).
Submitted by Allergenetics (Mchenry, US). The FDA issued a Cleared decision on August 28, 1984, 29 days after receiving the submission on July 30, 1984.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K842969 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 30, 1984 |
| Decision Date | August 28, 1984 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | DGP — Ige, Fitc, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |