LIQUICHEK ELEVATED CRP CONTROL

Single (specified) Analyte Controls (assayed And Unassayed)

BIO-RAD

The following data is part of a premarket notification filed by Bio-rad with the FDA for Liquichek Elevated Crp Control.

Pre-market Notification Details

Device IDK042837
510k NumberK042837
Device Name:LIQUICHEK ELEVATED CRP CONTROL
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant BIO-RAD 9500 JERONIMO RD. Irvine,  CA  92618 -2017
ContactElizabeth Platt
CorrespondentElizabeth Platt
BIO-RAD 9500 JERONIMO RD. Irvine,  CA  92618 -2017
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-10-14
Decision Date2004-11-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847661001768 K042837 000
00847661000938 K042837 000
00847661000921 K042837 000
00847661000914 K042837 000

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