K864027 is an FDA 510(k) clearance for the BBL CAMPYSLIDE(TM) TEST. This device is classified as a Campylobacter Spp. (Class I - General Controls, product code LQP).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on December 11, 1986, 57 days after receiving the submission on October 15, 1986.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3110.
| 510(k) Number | K864027 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 1986 |
| Decision Date | December 11, 1986 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LQP — Campylobacter Spp. |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3110 |