COACUTE ANTITHROMBIN CHROMOGENIC ASSAY— 510(k) K902393

Name: FDA 510(k) clearance K902393
Creator: U.S. Food and Drug Administration
Published: 1990-09-25

Substantially Equivalent

Kabi Diagnostica

FDA 510(k) clearance K902393 for COACUTE ANTITHROMBIN CHROMOGENIC ASSAY, Substantially Equivalent on 1990-09-25. Applicant: Kabi Diagnostica. Device class: 2.

Clearance details

Applicant: Kabi Diagnostica
Product code: Code JBQ
Device class: Class 2
Regulation: 21 CFR 864.7060
Advisory panel: Hematology
Date received: 1990-05-30
Decision date: 1990-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danville, CA, US

Download summary PDF View on FDA.gov ↗

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