COACUTE ANTITHROMBIN CHROMOGENIC ASSAY— 510(k) K902393

Substantially Equivalent

Kabi Diagnostica

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

Clearance details

Applicant: Kabi Diagnostica
Product code: Code JBQ
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 ↗

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