K831827 is an FDA 510(k) clearance for the EGG YOLK AGAR. This device is classified as a Culture Media, Non-selective And Differential (Class I - General Controls, product code JSH).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on July 26, 1983, 49 days after receiving the submission on June 7, 1983.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2320.
| 510(k) Number | K831827 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 1983 |
| Decision Date | July 26, 1983 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JSH — Culture Media, Non-selective And Differential |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2320 |