510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K922376Substantially Equivalent

Icn Biomedicals Immuchem(tm) Fsh-Mw Elisa Kit

Icn Biomedicals, Inc., Costa Mesa CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922376 is the FDA 510(k) clearance record for ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT, a class I device, cleared for Icn Biomedicals, Inc. on under FDA product code CGJ (Radioimmunoassay, Follicle-Stimulating Hormone). FDA records list 11 510(k) clearances for Icn Biomedicals, Inc., from to . As of , FDA records show no recalls naming K922376.

Clearance record

Decision date
Received
(138 days to decision)
Product code
CGJ Radioimmunoassay, Follicle-Stimulating Hormone
Regulation
21 CFR 862.1300
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Icn Biomedicals, Inc. 3300 Hyland Ave., Costa Mesa CA
510(k) summary
Statement
Third party review
No

Clearances, product code CGJ

Trailing 12 months

FDA records hold no clearances under product code CGJ in the trailing twelve months.

FDA records show no clearances under product code CGJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CGJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260