IMMUCHEM PRL-MW ELISA— 510(k) K922715

Substantially Equivalent

Icn Biomedicals, Inc.

FDA 510(k) clearance K922715 for IMMUCHEM PRL-MW ELISA, Substantially Equivalent on 1992-10-05. Applicant: Icn Biomedicals, Inc.. Device class: 1.

Clearance details

Applicant: Icn Biomedicals, Inc.
Product code: Code CFT
Device class: Class 1
Regulation: 21 CFR 862.1625
Advisory panel: Clinical Chemistry
Date received: 1992-06-05
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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