K865021 is an FDA 510(k) clearance for the BACTEC(R) NR-660 HIGH PERFORMANCE 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 (Franklin Lakes, US). The FDA issued a Cleared decision on February 6, 1987, 45 days after receiving the submission on December 23, 1986.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2560.
| 510(k) Number | K865021 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 1986 |
| Decision Date | February 06, 1987 |
| Days to Decision | 45 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 |