K955451 is an FDA 510(k) clearance for the CVM TRANSPORT. This device is classified as a Culture Media, Non-propagating Transport (Class I - General Controls, product code JSM).
Submitted by Hardy Diagnostics (Santa Maria, US). The FDA issued a Cleared decision on July 22, 1996, 236 days after receiving the submission on November 29, 1995.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2390.
| 510(k) Number | K955451 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 29, 1995 |
| Decision Date | July 22, 1996 |
| Days to Decision | 236 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | JSM — Culture Media, Non-propagating Transport |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2390 |