COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY— 510(k) K952515

Name: FDA 510(k) clearance K952515
Creator: U.S. Food and Drug Administration
Published: 1996-01-23

Substantially Equivalent

Chromogenix AB

FDA 510(k) clearance K952515 for COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY, Substantially Equivalent on 1996-01-23. Applicant: Chromogenix AB. Device class: 2.

Clearance details

Applicant: Chromogenix AB
Product code: Code JBQ
Device class: Class 2
Regulation: 21 CFR 864.7060
Advisory panel: Hematology
Date received: 1995-05-31
Decision date: 1996-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin, OH, US

Download summary PDF View on FDA.gov ↗

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