K850731 is an FDA 510(k) clearance for the CULTURE MEDIUM FOR ANTIMICROBIAL SUSCEP. TESTING. This device is classified as a Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth (Class II - Special Controls, product code JTZ).
Submitted by Roseville Medical Laboratoriesu (Roseville, US). The FDA issued a Cleared decision on March 20, 1985, 28 days after receiving the submission on February 20, 1985.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1700.
| 510(k) Number | K850731 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 20, 1985 |
| Decision Date | March 20, 1985 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JTZ — Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1700 |