LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK

Multi-analyte Controls, All Kinds (assayed)

BIO-RAD, DIAGNOSTICS GRP.

The following data is part of a premarket notification filed by Bio-rad, Diagnostics Grp. with the FDA for Liquichek Microalbumin Control Level 1, Level 2, Control Minipak.

Pre-market Notification Details

Device IDK072835
510k NumberK072835
Device Name:LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant BIO-RAD, DIAGNOSTICS GRP. 9500 JERONIMO RD. Irvine,  CA  92618 -2017
ContactSuzanne Parsons
CorrespondentSuzanne Parsons
BIO-RAD, DIAGNOSTICS GRP. 9500 JERONIMO RD. Irvine,  CA  92618 -2017
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-10-03
Decision Date2007-12-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847661003441 K072835 000
00847661003434 K072835 000
00847661003427 K072835 000

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