LIQUICHEK D-DIMER CONTROL, MODEL 356, 357


Device Classification Name

plasma, coagulation control

510(k) Number K030182
Device Name LIQUICHEK D-DIMER CONTROL, MODEL 356, 357
Original Applicant
BIO-RAD
9500 jeronimo rd.
irvine, 
CA 
92618 -2017

Original Contact elizabeth platt
Regulation Number 864.5425
Classification Product Code
GGN  
Subsequent Product Code
DAP  
Date Received 01/17/2003
Decision Date 02/24/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No