K071934 is an FDA 510(k) clearance for the MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT. This device is classified as a Centrifuges (micro, Ultra, Refrigerated) For Clinical Use (Class I - General Controls, product code JQC).
Submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on October 11, 2007, 90 days after receiving the submission on July 13, 2007.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 862.2050.
| 510(k) Number | K071934 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 2007 |
| Decision Date | October 11, 2007 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | JQC — Centrifuges (micro, Ultra, Refrigerated) For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2050 |