K822715 is an FDA 510(k) clearance for the PLATELET CENTRIFUGE. This device is classified as a Centrifuges (micro, Ultra, Refrigerated) For Clinical Use (Class I - General Controls, product code JQC).
Submitted by Biodynamics Corp. (Mchenry, US). The FDA issued a Cleared decision on September 30, 1982, 23 days after receiving the submission on September 7, 1982.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 862.2050.
| 510(k) Number | K822715 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 07, 1982 |
| Decision Date | September 30, 1982 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | JQC — Centrifuges (micro, Ultra, Refrigerated) For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2050 |