CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50


Device Classification Name

antithrombin iii quantitation

510(k) Number K023991
Device Name CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50
Original Applicant
PRECISION BIOLOGIC
900 windmill rd., suite 100
dartmouth, n.s., 

CA

b3b 1p7

Original Contact stephen l duff
Regulation Number 864.7060
Classification Product Code
JBQ  
Date Received 12/03/2002
Decision Date 04/28/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No