K854986 is an FDA 510(k) clearance for the BBL PORT-A-CUL AEROBIC TRANSPORT SYS, MODIFIED STU. This device is classified as a Culture Media, Non-propagating Transport (Class I - General Controls, product code JSM).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Paramus, US). The FDA issued a Cleared decision on January 3, 1986, 22 days after receiving the submission on December 12, 1985.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2390.
| 510(k) Number | K854986 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 1985 |
| Decision Date | January 03, 1986 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JSM — Culture Media, Non-propagating Transport |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2390 |