K933878 is an FDA 510(k) clearance for the ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT. This device is classified as a Counter, Differential Cell (Class II - Special Controls, product code GKZ).
Submitted by Intracel Corp. (Cambridge, US). The FDA issued a Cleared decision on November 14, 1995, 827 days after receiving the submission on August 9, 1993.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5220.
| 510(k) Number | K933878 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 1993 |
| Decision Date | November 14, 1995 |
| Days to Decision | 827 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GKZ — Counter, Differential Cell |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5220 |