CHEM-ASSAY STANDARD-CONTROLS— 510(k) K802962

Name: FDA 510(k) clearance K802962
Creator: U.S. Food and Drug Administration
Published: 1980-12-22

Substantially Equivalent

National Bio-Technical Laboratories

FDA 510(k) clearance K802962 for CHEM-ASSAY STANDARD-CONTROLS, Substantially Equivalent on 1980-12-22. Applicant: National Bio-Technical Laboratories. Device class: 1.

Clearance details

Applicant: National Bio-Technical Laboratories
Product code: Code JJY
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1980-11-21
Decision date: 1980-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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