K771058 is an FDA 510(k) clearance for the EPTONE BACK-UP BROTH, 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 July 1, 1977, 18 days after receiving the submission on June 13, 1977.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2900.
| 510(k) Number | K771058 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 13, 1977 |
| Decision Date | July 01, 1977 |
| Days to Decision | 18 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 |