BINAX PROLACTIN IRMA DIAGNOSTIC KIT— 510(k) K880218

Name: FDA 510(k) clearance K880218
Creator: U.S. Food and Drug Administration
Published: 1988-03-01

Substantially Equivalent

Binax, Inc.

FDA 510(k) clearance K880218 for BINAX PROLACTIN IRMA DIAGNOSTIC KIT, Substantially Equivalent on 1988-03-01. Applicant: Binax, Inc.. Device class: 1.

Clearance details

Applicant: Binax, Inc.
Product code: Code CFT
Device class: Class 1
Regulation: 21 CFR 862.1625
Advisory panel: Clinical Chemistry
Date received: 1988-01-20
Decision date: 1988-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: S. Portland, ME, US

Download summary PDF View on FDA.gov ↗

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