K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT


codes

Device Classification Name

fibrinogen and fibrin split products, antigen, antiserum, control

510(k) Number K002948
Device Name K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT
Original Applicant
KAMIYA BIOMEDICAL CO.
910 industry dr.
seattle, 
WA 
98188 -3412

Original Contact colin getty
Regulation Number 864.7320
Classification Product Code
DAP  
Date Received 09/21/2000
Decision Date 05/18/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized