BINAS LUTEINIZING HORMONE IRMA TEST KIT— 510(k) K883306

Name: FDA 510(k) clearance K883306
Creator: U.S. Food and Drug Administration
Published: 1988-10-06

Substantially Equivalent

Binax, Inc.

FDA 510(k) clearance K883306 for BINAS LUTEINIZING HORMONE IRMA TEST KIT, Substantially Equivalent on 1988-10-06. Applicant: Binax, Inc.. Device class: 2.

Clearance details

Applicant: Binax, Inc.
Product code: Code JIT
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1988-08-04
Decision date: 1988-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: S. Portland, ME, US

Download summary PDF View on FDA.gov ↗

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