510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K933878Substantially Equivalent

Zymmune(tm) Cd4/cd8 Cell Monitoring Kit

Intracel Corp., Cambridge MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K933878 is the FDA 510(k) clearance record for ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT, a class II device, cleared for Intracel Corp. on under FDA product code GKZ (Counter, Differential Cell). FDA records list 5 510(k) clearances for Intracel Corp., from to . As of , FDA records show no recalls naming K933878.

Clearance record

Decision date
Received
(827 days to decision)
Product code
GKZ Counter, Differential Cell
Regulation
21 CFR 864.5220
Device class
Class II
Review panel
Hematology
Applicant
Intracel Corp. 359 Allston St., Cambridge MA
510(k) summary
Summary
Third party review
No

Clearances, product code GKZ

Trailing 12 months
4 clearances under product code GKZ in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GKZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20261
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260