K990579 is an FDA 510(k) clearance for the CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML). This device is classified as a Reagent, Russel Viper Venom (Class I - General Controls, product code GIR).
Submitted by Precision Biologic (Dartmouth, N.S., CA). The FDA issued a Cleared decision on July 23, 1999, 150 days after receiving the submission on February 23, 1999.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8950.
| 510(k) Number | K990579 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 1999 |
| Decision Date | July 23, 1999 |
| Days to Decision | 150 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | GIR — Reagent, Russel Viper Venom |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.8950 |