ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT— 510(k) K922376

Name: FDA 510(k) clearance K922376
Creator: U.S. Food and Drug Administration
Published: 1992-10-05

Substantially Equivalent

Icn Biomedicals, Inc.

FDA 510(k) clearance K922376 for ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT, Substantially Equivalent on 1992-10-05. Applicant: Icn Biomedicals, Inc.. Device class: 1.

Clearance details

Applicant: Icn Biomedicals, Inc.
Product code: Code CGJ
Device class: Class 1
Regulation: 21 CFR 862.1300
Advisory panel: Clinical Chemistry
Date received: 1992-05-20
Decision date: 1992-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, US

Download summary PDF View on FDA.gov ↗

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