K891907 is an FDA 510(k) clearance for the QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED. 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 April 11, 1989, 15 days after receiving the submission on March 27, 1989.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8625.
| 510(k) Number | K891907 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 1989 |
| Decision Date | April 11, 1989 |
| Days to Decision | 15 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 |