K003534 is an FDA 510(k) clearance for the PENTRA 5D. 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 December 1, 2000, 15 days after receiving the submission on November 16, 2000.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8625.
| 510(k) Number | K003534 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 16, 2000 |
| Decision Date | December 01, 2000 |
| Days to Decision | 15 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 |