K874320 is an FDA 510(k) clearance for the CELLECT LABTRAK SOFTWARE. This device is classified as a Counter, Cell, Automated (particle Counter) (Class II - Special Controls, product code GKL).
Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on January 27, 1988, 98 days after receiving the submission on October 21, 1987.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5200.
| 510(k) Number | K874320 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 21, 1987 |
| Decision Date | January 27, 1988 |
| Days to Decision | 98 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 |