K822445 is an FDA 510(k) clearance for the HCT CENTRIFUGE. This device is classified as a Centrifuge, Hematocrit (Class II - Special Controls, product code GKG).
Submitted by Boehringer Mannheim Corp. (Mchenry, US). The FDA issued a Cleared decision on September 14, 1982, 29 days after receiving the submission on August 16, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.6400.
| 510(k) Number | K822445 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 16, 1982 |
| Decision Date | September 14, 1982 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | GKG — Centrifuge, Hematocrit |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.6400 |