LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK


Device Classification Name

multi-analyte controls, all kinds (assayed)

510(k) Number K072835
Device Name LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK
Applicant
BIO-RAD, DIAGNOSTICS GRP.
9500 jeronimo rd.
irvine, 
CA 
92618 -2017

Applicant Contact suzanne parsons
Correspondent
BIO-RAD, DIAGNOSTICS GRP.
9500 jeronimo rd.
irvine, 
CA 
92618 -2017

Correspodent Contact suzanne parsons
Regulation Number 862.1660
Classification Product Code
JJY  
Date Received 10/03/2007
Decision Date 12/11/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No