K782049 is an FDA 510(k) clearance for the BIOASSAY SYSTEM, MS-2 SERUM. This device is classified as a Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep. (Class II - Special Controls, product code DJB).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 28, 1979, 263 days after receiving the submission on December 8, 1978.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 862.3450.
| 510(k) Number | K782049 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 08, 1978 |
| Decision Date | August 28, 1979 |
| Days to Decision | 263 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | DJB — Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3450 |