K010409 is an FDA 510(k) clearance for the CBC-SF. This device is classified as a Mixture, Hematology Quality Control (Class II - Special Controls, product code JPK).
Submitted by R&D Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on March 16, 2001, 32 days after receiving the submission on February 12, 2001.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8625.
| 510(k) Number | K010409 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 12, 2001 |
| Decision Date | March 16, 2001 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | JPK — Mixture, Hematology Quality Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.8625 |