K843619 is an FDA 510(k) clearance for the RETIC-SET. This device is classified as a Stains, Hematology (Class I - General Controls, product code KQC).
Submitted by R&D Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on October 30, 1984, 46 days after receiving the submission on September 14, 1984.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.1850.
| 510(k) Number | K843619 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 14, 1984 |
| Decision Date | October 30, 1984 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | KQC — Stains, Hematology |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.1850 |