K790366 is an FDA 510(k) clearance for the URINE CULTURE KIT. This device is classified as a System, Transport, Aerobic (Class I - General Controls, product code JTW).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on April 4, 1979, 41 days after receiving the submission on February 22, 1979.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2900.
| 510(k) Number | K790366 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 22, 1979 |
| Decision Date | April 04, 1979 |
| Days to Decision | 41 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 |