K841848 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. (Mchenry, US). The FDA issued a Cleared decision on May 31, 1984, 64 days after receiving the submission on March 28, 1984.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.1850.
| 510(k) Number | K841848 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 1984 |
| Decision Date | May 31, 1984 |
| Days to Decision | 64 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 |