LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY

Multi-analyte Controls, All Kinds (assayed)

Bio-Rad Laboratories

The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Liquichek Immunoassay Premium Control-trilevel, Liquichek Immunoassay Premium Control-level I, Liquichek Immunoassay.

Pre-market Notification Details

Device IDK132227
510k NumberK132227
Device Name:LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant Bio-Rad Laboratories 9500 JERONIMO RD. Irvine,  CA  92618 -2017
ContactSuzanne Parsons
CorrespondentSuzanne Parsons
Bio-Rad Laboratories 9500 JERONIMO RD. Irvine,  CA  92618 -2017
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-07-17
Decision Date2013-10-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847661005193 K132227 000
00847661005186 K132227 000
00847661005179 K132227 000
00847661005162 K132227 000
00847661005155 K132227 000

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