COATEST LMW HEPARIN/HEPARIN CHROMOGENIC ASSAY— 510(k) K901874

Name: FDA 510(k) clearance K901874
Creator: U.S. Food and Drug Administration
Published: 1990-07-20

Substantially Equivalent

Kabi Diagnostica

FDA 510(k) clearance K901874 for COATEST LMW HEPARIN/HEPARIN CHROMOGENIC ASSAY, Substantially Equivalent on 1990-07-20. Applicant: Kabi Diagnostica. Device class: 2.

Clearance details

Applicant: Kabi Diagnostica
Product code: Code KFF
Device class: Class 2
Regulation: 21 CFR 864.7525
Advisory panel: Hematology
Date received: 1990-04-26
Decision date: 1990-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danville, CA, US

Download summary PDF View on FDA.gov ↗

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