LYMPHO SEP(TM)— 510(k) K902445

Substantially Equivalent

Icn Biomedicals, Inc.

FDA 510(k) clearance K902445 for LYMPHO SEP(TM), Substantially Equivalent on 1990-08-22. Applicant: Icn Biomedicals, Inc.. Device class: 1.

Clearance details

Applicant: Icn Biomedicals, Inc.
Product code: Code JCF
Device class: Class 1
Regulation: 21 CFR 864.8500
Advisory panel: Hematology
Date received: 1990-06-01
Decision date: 1990-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.