IMMUCHEM PHE-MW EA— 510(k) K926106

Substantially Equivalent

Icn Biomedicals, Inc.

FDA 510(k) clearance K926106 for IMMUCHEM PHE-MW EA, Substantially Equivalent on 1995-02-08. Applicant: Icn Biomedicals, Inc.. Device class: 2.

Clearance details

Applicant: Icn Biomedicals, Inc.
Product code: Code JNB
Device class: Class 2
Regulation: 21 CFR 862.1555
Advisory panel: Clinical Chemistry
Date received: 1992-12-03
Decision date: 1995-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, US

Download summary PDF View on FDA.gov ↗

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