K843341 is an FDA 510(k) clearance for the GONO-PAK W/THAYER-MARTIN AGAR/GONO-PAK. This device is classified as a System, Transport, Aerobic (Class I - General Controls, product code JTW).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Walker, US). The FDA issued a Cleared decision on September 27, 1984, 31 days after receiving the submission on August 27, 1984.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2900.
| 510(k) Number | K843341 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 27, 1984 |
| Decision Date | September 27, 1984 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JTW — System, Transport, Aerobic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2900 |