K792276 is an FDA 510(k) clearance for the BRAIN HEART INFUSION W/PABA, O.1%,. This device is classified as a Culture Media, Non-selective And Non-differential (Class I - General Controls, product code JSG).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on December 19, 1979, 36 days after receiving the submission on November 13, 1979.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2300.
| 510(k) Number | K792276 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 1979 |
| Decision Date | December 19, 1979 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JSG — Culture Media, Non-selective And Non-differential |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2300 |