K822716 is an FDA 510(k) clearance for the UNIVERSAL CENTRIFUGE. This device is classified as a Device, Hematocrit Measuring (Class II - Special Controls, product code JPI).
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 864.6400.
| 510(k) Number | K822716 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 | JPI — Device, Hematocrit Measuring |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.6400 |