VISUWELL REAGIN TEST 960 TEST KIT— 510(k) K885298

Name: FDA 510(k) clearance K885298
Creator: U.S. Food and Drug Administration
Published: 1989-03-15

Substantially Equivalent

Allelix Diagnostics, Inc.

FDA 510(k) clearance K885298 for VISUWELL REAGIN TEST 960 TEST KIT, Substantially Equivalent on 1989-03-15. Applicant: Allelix Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Allelix Diagnostics, Inc.
Product code: Code GMP
Device class: Class 2
Regulation: 21 CFR 866.3820
Advisory panel: Microbiology
Date received: 1988-12-27
Decision date: 1989-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada L4v 1p1, CA

Download summary PDF View on FDA.gov ↗

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