K803219 is an FDA 510(k) clearance for the ADC-500 AUTOMATED DIFFER. CELL CNTR. SY.. 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 January 21, 1981, 33 days after receiving the submission on December 19, 1980.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 864.5220.
| 510(k) Number | K803219 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 1980 |
| Decision Date | January 21, 1981 |
| Days to Decision | 33 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GKZ — Counter, Differential Cell |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5220 |