K760942 is an FDA 510(k) clearance for the GENTASAK. This device is classified as a Bacillus Subtilis, Microbiological Assay, Gentamicin (Class II - Special Controls, product code DKD).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on March 7, 1977, 126 days after receiving the submission on November 1, 1976.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.3450.
| 510(k) Number | K760942 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 1976 |
| Decision Date | March 07, 1977 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DKD — Bacillus Subtilis, Microbiological Assay, Gentamicin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3450 |