K971226 is an FDA 510(k) clearance for the CRYO CHECK FACTOR IX DEFICIENT PLASMA. This device is classified as a Plasma, Coagulation Factor Deficient (Class II - Special Controls, product code GJT).
Submitted by Precision Biologicals, Inc. (Dartmouth, Nova Scotia, CA). The FDA issued a Cleared decision on July 18, 1997, 107 days after receiving the submission on April 2, 1997.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7290.
| 510(k) Number | K971226 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 02, 1997 |
| Decision Date | July 18, 1997 |
| Days to Decision | 107 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | GJT — Plasma, Coagulation Factor Deficient |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7290 |