K791867 is an FDA 510(k) clearance for the ROYCO MODEL 921 CELL COUNTER. This device is classified as a Counter, Cell, Automated (particle Counter) (Class II - Special Controls, product code GKL).
Submitted by Royco Instruments (Mchenry, US). The FDA issued a Cleared decision on November 5, 1979, 45 days after receiving the submission on September 21, 1979.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5200.
| 510(k) Number | K791867 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 21, 1979 |
| Decision Date | November 05, 1979 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GKL — Counter, Cell, Automated (particle Counter) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5200 |