K021150 is an FDA 510(k) clearance for the COULTER CELLPREP. This device is classified as a Apparatus, Automated Blood Cell Diluting (Class I - General Controls, product code GKH).
Submitted by Beckman Coulter, Inc. (Miami, US). The FDA issued a Cleared decision on June 11, 2002, 62 days after receiving the submission on April 10, 2002.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5240.
| 510(k) Number | K021150 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 2002 |
| Decision Date | June 11, 2002 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GKH — Apparatus, Automated Blood Cell Diluting |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.5240 |