ALLELIX GROUP A STREPTOCOCCUS DETECTION KIT— 510(k) K871620

Name: FDA 510(k) clearance K871620
Creator: U.S. Food and Drug Administration
Published: 1987-06-17

Substantially Equivalent

Allelix, Inc.

FDA 510(k) clearance K871620 for ALLELIX GROUP A STREPTOCOCCUS DETECTION KIT, Substantially Equivalent on 1987-06-17. Applicant: Allelix, Inc.. Device class: 1.

Clearance details

Applicant: Allelix, Inc.
Product code: Code GTZ
Device class: Class 1
Regulation: 21 CFR 866.3740
Advisory panel: Microbiology
Date received: 1987-04-27
Decision date: 1987-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada L4v 1p1, CA

Download summary PDF View on FDA.gov ↗

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