K770441 is an FDA 510(k) clearance for the GAR, COLUMBIA, W/5% HORSE BLOOD. This device is classified as a Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (Class II - Special Controls, product code JSO).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on March 10, 1977, 3 days after receiving the submission on March 7, 1977.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1700.
| 510(k) Number | K770441 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 1977 |
| Decision Date | March 10, 1977 |
| Days to Decision | 3 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JSO — Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1700 |