K770244 is an FDA 510(k) clearance for the AUTO DIFFERENTIAL CELL COUNTER SYSTEM. This device is classified as a Counter, Differential Cell (Class II - Special Controls, product code GKZ).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 4, 1977, 178 days after receiving the submission on February 7, 1977.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5220.
| 510(k) Number | K770244 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 1977 |
| Decision Date | August 04, 1977 |
| Days to Decision | 178 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GKZ — Counter, Differential Cell |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5220 |