COAMATIC AT-400


Device Classification Name

antithrombin iii quantitation

510(k) Number K022195
Device Name COAMATIC AT-400
Original Applicant
INSTRUMENTATION LABORATORY CO.
180 hartwell road
bedford, 
MA 
01730

Original Contact carol marble
Regulation Number 864.7060
Classification Product Code
JBQ  
Date Received 07/05/2002
Decision Date 08/07/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No