K972359 is an FDA 510(k) clearance for the REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN. This device is classified as a Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (Class II - Special Controls, product code JSO).
Submitted by Remel, L.P. (Lenexa, US). The FDA issued a Cleared decision on August 28, 1997, 64 days after receiving the submission on June 25, 1997.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1700.
| 510(k) Number | K972359 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 1997 |
| Decision Date | August 28, 1997 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | JSO — Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1700 |