K853011 is an FDA 510(k) clearance for the BACTEC NR-730 BACTERIAL DETECTION SYSTEM. This device is classified as a Monitor, Microbial Growth (Class I - General Controls, product code JTA).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Paramus, US). The FDA issued a Cleared decision on July 30, 1985, 14 days after receiving the submission on July 16, 1985.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2560.
| 510(k) Number | K853011 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 1985 |
| Decision Date | July 30, 1985 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JTA — Monitor, Microbial Growth |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2560 |