K781674 is an FDA 510(k) clearance for the MACRO-VUE TEST, GENTAMICIN. This device is classified as a Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep. (Class II - Special Controls, product code DJB).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on November 15, 1978, 43 days after receiving the submission on October 3, 1978.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3450.
| 510(k) Number | K781674 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 1978 |
| Decision Date | November 15, 1978 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DJB — Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3450 |