K852016 is an FDA 510(k) clearance for the LASER PLATELETCAL/MULTIPLE. This device is classified as a Calibrator For Platelet Counting (Class II - Special Controls, product code KRY).
Submitted by R&D Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on July 9, 1985, 61 days after receiving the submission on May 9, 1985.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8175.
| 510(k) Number | K852016 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 1985 |
| Decision Date | July 09, 1985 |
| Days to Decision | 61 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | KRY — Calibrator For Platelet Counting |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.8175 |