K100607 is an FDA 510(k) clearance for the COULTER 4C-EX 300 CELL CONTROL. 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 November 18, 2010, 260 days after receiving the submission on March 3, 2010.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8625.
| 510(k) Number | K100607 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 2010 |
| Decision Date | November 18, 2010 |
| Days to Decision | 260 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 |