K897060 is an FDA 510(k) clearance for the CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE. This device is classified as a Calibrator For Red-cell And White-cell Counting (Class II - Special Controls, product code KSA).
Submitted by R&D Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on January 2, 1990, 15 days after receiving the submission on December 18, 1989.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8185.
| 510(k) Number | K897060 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 18, 1989 |
| Decision Date | January 02, 1990 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | KSA — Calibrator For Red-cell And White-cell Counting |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.8185 |