LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL


Device Classification Name

enzyme controls (assayed and unassayed)

510(k) Number K021498
Device Name LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL
Original Applicant
BIO-RAD
9500 jeronimo rd.
irvine, 
CA 
92618

Original Contact maria zeballos
Regulation Number 862.1660
Classification Product Code
JJT  
Date Received 05/09/2002
Decision Date 05/24/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No