K792606 is an FDA 510(k) clearance for the WHOLE BLOOD PLATELET CONTROL NORMAL,. This device is classified as a Mixture, Hematology Quality Control (Class II - Special Controls, product code JPK).
Submitted by Dade, Baxter Travenol Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 13, 1980, 57 days after receiving the submission on December 18, 1979.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8625.
| 510(k) Number | K792606 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 18, 1979 |
| Decision Date | February 13, 1980 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | JPK — Mixture, Hematology Quality Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.8625 |