K021927 is an FDA 510(k) clearance for the PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM. This device is classified as a Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use (Class I - General Controls, product code LXG).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 12, 2002, 30 days after receiving the submission on June 12, 2002.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 862.2050.
| 510(k) Number | K021927 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 12, 2002 |
| Decision Date | July 12, 2002 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | LXG — Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2050 |