AMER. BIO-SCIENCE LAB CORTISOL REAGENT— 510(k) K842455

Name: FDA 510(k) clearance K842455
Creator: U.S. Food and Drug Administration
Published: 1984-08-16

Substantially Equivalent

American Bio-Science Laboratories

FDA 510(k) clearance K842455 for AMER. BIO-SCIENCE LAB CORTISOL REAGENT, Substantially Equivalent on 1984-08-16. Applicant: American Bio-Science Laboratories. Device class: 2.

Clearance details

Applicant: American Bio-Science Laboratories
Product code: Code CGR
Device class: Class 2
Regulation: 21 CFR 862.1205
Advisory panel: Clinical Chemistry
Date received: 1984-06-22
Decision date: 1984-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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