K934497 is an FDA 510(k) clearance for the CBC-STK(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 6, 1993, 83 days after receiving the submission on September 14, 1993.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8625.
| 510(k) Number | K934497 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 14, 1993 |
| Decision Date | December 06, 1993 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | JCN — Control, Cell Counter, Normal And Abnormal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.8625 |