COALIZA PROTEIN S-FREE


definition

Device Classification Name

test, qualitative and quantitative factor deficiency

510(k) Number K002467
Device Name COALIZA PROTEIN S-FREE
Original Applicant
INSTRUMENTATION LABORATORY CO.
180 hartwell road
bedford, 
MA 
01730

Original Contact carol marble
Regulation Number 864.7290
Classification Product Code
GGP  
Date Received 08/11/2000
Decision Date 10/13/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

Type Traditional
Reviewed by Third Party No

Combination Product

No