BINAX EQUATE GLYCOHEMOGLOBIN— 510(k) K874749

Substantially Equivalent

Binax, Inc.

FDA 510(k) clearance K874749 for BINAX EQUATE GLYCOHEMOGLOBIN, Substantially Equivalent on 1988-08-12. 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: 1987-11-18
Decision date: 1988-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: S. Portland, ME, US

Download summary PDF View on FDA.gov ↗

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