510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K954188Substantially Equivalent

Opticlone Igg1 Fitc/igg2a Pe Isotypic Control

IMMUNOTECH s.r.o., Westbrook ME / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954188 is the FDA 510(k) clearance record for OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROL, a class II device, cleared for Immunotech Corp. on under FDA product code GKZ (Counter, Differential Cell). FDA records list 42 510(k) clearances for IMMUNOTECH s.r.o., from to . As of , FDA records show no recalls naming K954188.

Clearance record

Decision date
Received
(58 days to decision)
Product code
GKZ Counter, Differential Cell
Regulation
21 CFR 864.5220
Device class
Class II
Review panel
Hematology
Applicant
Immunotech Corp. 160 B Larrabee Rd., Westbrook ME
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