K912357 is an FDA 510(k) clearance for the 3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE. This device is classified as a Calibrator For Cell Indices (Class II - Special Controls, product code KRX).
Submitted by R&D Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on July 9, 1991, 42 days after receiving the submission on May 28, 1991.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8150.
| 510(k) Number | K912357 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 28, 1991 |
| Decision Date | July 09, 1991 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | KRX — Calibrator For Cell Indices |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.8150 |