K760054 is an FDA 510(k) clearance for the CULTURE TUBE, (VACUTAINER). 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 August 3, 1976, 48 days after receiving the submission on June 16, 1976.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2900.
| 510(k) Number | K760054 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 16, 1976 |
| Decision Date | August 03, 1976 |
| Days to Decision | 48 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 |