K840294 is an FDA 510(k) clearance for the GROUP A SELECTIVE AGAR W/5% SHEEP BLOOD. This device is classified as a Culture Media, Selective And Differential (Class I - General Controls, product code JSI).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on February 17, 1984, 24 days after receiving the submission on January 24, 1984.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2360.
| 510(k) Number | K840294 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 1984 |
| Decision Date | February 17, 1984 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JSI — Culture Media, Selective And Differential |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2360 |