K945911 is an FDA 510(k) clearance for the CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARS. This device is classified as a Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth (Class II - Special Controls, product code JTZ).
Submitted by Bioclinical Systems, Inc. (Annapolis Junction, US). The FDA issued a Cleared decision on April 4, 1995, 123 days after receiving the submission on December 2, 1994.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1700.
| 510(k) Number | K945911 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 1994 |
| Decision Date | April 04, 1995 |
| Days to Decision | 123 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | JTZ — Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1700 |