K854064 is an FDA 510(k) clearance for the BCYE (BUFFERED CHARCOAL YEAST EXTRACT) AGAR. This device is classified as a Culture Media, Enriched (Class I - General Controls, product code KZI).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Paramus, US). The FDA issued a Cleared decision on October 23, 1985, 19 days after receiving the submission on October 4, 1985.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2330.
| 510(k) Number | K854064 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 04, 1985 |
| Decision Date | October 23, 1985 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | KZI — Culture Media, Enriched |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2330 |