K842747 is an FDA 510(k) clearance for the HYCEL DILUTOR, VARIOUS MODELS/MULTI. This device is classified as a Apparatus, Automated Blood Cell Diluting (Class I - General Controls, product code GKH).
Submitted by R&D Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 1, 1984, 80 days after receiving the submission on July 13, 1984.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5240.
| 510(k) Number | K842747 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 1984 |
| Decision Date | October 01, 1984 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GKH — Apparatus, Automated Blood Cell Diluting |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.5240 |