K925863 is an FDA 510(k) clearance for the SPUNCRIT. This device is classified as a Centrifuge, Hematocrit (Class II - Special Controls, product code GKG).
Submitted by bioMerieux, Inc. (Bethlehem, US). The FDA issued a Cleared decision on February 5, 1993, 78 days after receiving the submission on November 19, 1992.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.6400.
| 510(k) Number | K925863 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 19, 1992 |
| Decision Date | February 05, 1993 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GKG — Centrifuge, Hematocrit |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.6400 |