UCG-BETA SLIDE MONOCLONAL— 510(k) K831775

Substantially Equivalent

Armkel, LLC

FDA 510(k) clearance K831775 for UCG-BETA SLIDE MONOCLONAL, Substantially Equivalent on 1983-08-11. Applicant: Armkel, LLC. Device class: 2.

Clearance details

Applicant: Armkel, LLC
Product code: Code JHJ
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 1983-06-02
Decision date: 1983-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.