K010064 is an FDA 510(k) clearance for the 4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190. This device is classified as a Mixture, Hematology Quality Control (Class II - Special Controls, product code JPK).
Submitted by Beckman Coulter, Inc. (Miami, US). The FDA issued a Cleared decision on February 7, 2001, 30 days after receiving the submission on January 8, 2001.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8625.
| 510(k) Number | K010064 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 08, 2001 |
| Decision Date | February 07, 2001 |
| Days to Decision | 30 days |
| Submission Type | Special |
| 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 |