K800541 is an FDA 510(k) clearance for the CAMPYLOBACTER AGAR W/5-ANTIMICROBICS. This device is classified as a Culture Media, Selective And Non-differential (Class I - General Controls, product code JSJ).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on April 4, 1980, 25 days after receiving the submission on March 10, 1980.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2360.
| 510(k) Number | K800541 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 1980 |
| Decision Date | April 04, 1980 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JSJ — Culture Media, Selective And Non-differential |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2360 |