LIQUICHEK IMMUNOASSAY PLUS CONTROL, MODEL 360, 361, 362, 363

Multi-analyte Controls, All Kinds (assayed)

BIO-RAD

The following data is part of a premarket notification filed by Bio-rad with the FDA for Liquichek Immunoassay Plus Control, Model 360, 361, 362, 363.

Pre-market Notification Details

Device IDK001373
510k NumberK001373
Device Name:LIQUICHEK IMMUNOASSAY PLUS CONTROL, MODEL 360, 361, 362, 363
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant BIO-RAD 9500 JERONIMO RD. Irvine,  CA  92618 -2017
ContactElizabeth Platt
CorrespondentElizabeth Platt
BIO-RAD 9500 JERONIMO RD. Irvine,  CA  92618 -2017
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-05-01
Decision Date2000-05-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03610520267332 K001373 000
03610520267325 K001373 000
03610520267318 K001373 000
03610520267301 K001373 000
00847661001775 K001373 000
00847661001140 K001373 000
00847661001133 K001373 000
00847661001126 K001373 000
00847661001119 K001373 000

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