LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, AND 3-1 ML, MODEL 591, 592, 593; LEVEL 1, 2, AND 3-3 ML, MODEL 594, 595, 596


Device Classification Name

multi-analyte controls, all kinds (assayed)

510(k) Number K022991
Device Name LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, AND 3-1 ML, MODEL 591, 592, 593; LEVEL 1, 2, AND 3-3 ML, MODEL 594, 595, 596
Original Applicant
BIO-RAD
9500 jeronimo rd.
irvine, 
CA 
92618

Original Contact maria zeballos
Regulation Number 862.1660
Classification Product Code
JJY  
Date Received 09/09/2002
Decision Date 09/17/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Immunology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No