ANI BIOCARD(TM) HCG TEST— 510(k) K933794

Name: FDA 510(k) clearance K933794
Creator: U.S. Food and Drug Administration
Published: 1994-05-19

Substantially Equivalent

Canadian Bioclinical, Ltd.

FDA 510(k) clearance K933794 for ANI BIOCARD(TM) HCG TEST, Substantially Equivalent on 1994-05-19. Applicant: Canadian Bioclinical, Ltd.. Device class: 2.

Clearance details

Applicant: Canadian Bioclinical, Ltd.
Product code: Code LCX
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 1993-08-04
Decision date: 1994-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario, Canada, CA

Download summary PDF View on FDA.gov ↗

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