BINAX EQUATE(R) GLYCOHEMOGLOBIN 3 MINUTE TEST KIT— 510(k) K912748

Name: FDA 510(k) clearance K912748
Creator: U.S. Food and Drug Administration
Published: 1991-10-31

Substantially Equivalent

Binax, Inc.

FDA 510(k) clearance K912748 for BINAX EQUATE(R) GLYCOHEMOGLOBIN 3 MINUTE TEST KIT, Substantially Equivalent on 1991-10-31. Applicant: Binax, Inc.. Device class: 2.

Clearance details

Applicant: Binax, Inc.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 1991-06-21
Decision date: 1991-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: S. Portland, ME, US

Download summary PDF View on FDA.gov ↗

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