K874386 is an FDA 510(k) clearance for the CBC-TECH(TM) HEMATOLOGY CONTROL/MULTIPLE. This device is classified as a Control, Cell Counter, Normal And Abnormal (Class II - Special Controls, product code JCN).
Submitted by R&D Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on December 30, 1987, 65 days after receiving the submission on October 26, 1987.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8625.
| 510(k) Number | K874386 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 26, 1987 |
| Decision Date | December 30, 1987 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | JCN — Control, Cell Counter, Normal And Abnormal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.8625 |