K881115 is an FDA 510(k) clearance for the BACTEC(R) NR26 AND BACTEC(R) NR 27 CULTURE MEDIA. This device is classified as a Culture Media, Non-selective And Non-differential (Class I - General Controls, product code JSG).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on March 24, 1988, 9 days after receiving the submission on March 15, 1988.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2300.
| 510(k) Number | K881115 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 15, 1988 |
| Decision Date | March 24, 1988 |
| Days to Decision | 9 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JSG — Culture Media, Non-selective And Non-differential |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2300 |