K973211 is an FDA 510(k) clearance for the FRESH CELLS MV1LU. This device is classified as a Cells, Animal And Human, Cultured (Class I - General Controls, product code KIR).
Submitted by Diagnostic Hybrids, Inc. (Athens, US). The FDA issued a Cleared decision on September 25, 1997, 29 days after receiving the submission on August 27, 1997.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 864.2280.
| 510(k) Number | K973211 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 27, 1997 |
| Decision Date | September 25, 1997 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | KIR — Cells, Animal And Human, Cultured |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.2280 |