MINIQUANT D-DIMER, MODEL 1447


codes

Device Classification Name

fibrinogen and fibrin split products, antigen, antiserum, control

510(k) Number K002642
Device Name MINIQUANT D-DIMER, MODEL 1447
Original Applicant
BIOPOOL INTL., INC.
6025 nicolle st.
ventura, 
CA 
93003

Original Contact michael d bick
Regulation Number 864.7320
Classification Product Code
DAP  
Date Received 08/24/2000
Decision Date 02/05/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

Type Traditional
Reviewed by Third Party No

Combination Product

No