K913192 is an FDA 510(k) clearance for the SIMULTEST(TM) IMK-LYMPHOCYTE. This device is classified as a Counter, Differential Cell (Class II - Special Controls, product code GKZ).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on February 6, 1992, 203 days after receiving the submission on July 18, 1991.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5220.
| 510(k) Number | K913192 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 1991 |
| Decision Date | February 06, 1992 |
| Days to Decision | 203 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | GKZ — Counter, Differential Cell |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5220 |