CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50— 510(k) K023991

Name: FDA 510(k) clearance K023991
Creator: U.S. Food and Drug Administration
Published: 2003-04-28

Substantially Equivalent

Precision Biologic

FDA 510(k) clearance K023991 for CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50, Substantially Equivalent on 2003-04-28. Applicant: Precision Biologic. Device class: 2.

Clearance details

Applicant: Precision Biologic
Product code: Code JBQ
Device class: Class 2
Regulation: 21 CFR 864.7060
Advisory panel: Hematology
Date received: 2002-12-03
Decision date: 2003-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dartmouth, N.S., CA

Download summary PDF View on FDA.gov ↗

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