K961673 is an FDA 510(k) clearance for the R&D RETIC-PG HEMATOLOGY CONTROL. 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 July 15, 1996, 75 days after receiving the submission on May 1, 1996.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8625.
| 510(k) Number | K961673 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 1996 |
| Decision Date | July 15, 1996 |
| Days to Decision | 75 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 |