K952623 is an FDA 510(k) clearance for the CRYO CHECK LUPUS PLASMA. This device is classified as a Control, Plasma, Abnormal (Class II - Special Controls, product code GGC).
Submitted by Precision Biologicals, Inc. (Dartmouth, Nova Scotia, CA). The FDA issued a Cleared decision on November 6, 1995, 151 days after receiving the submission on June 8, 1995.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5425.
| 510(k) Number | K952623 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 08, 1995 |
| Decision Date | November 06, 1995 |
| Days to Decision | 151 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | GGC — Control, Plasma, Abnormal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5425 |