LIQUICHEK TORCH PLUS IGM CONTROL

Multi-analyte Controls, All Kinds (assayed)

BIO-RAD LABORATORIES, INC.

The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Liquichek Torch Plus Igm Control.

Pre-market Notification Details

Device IDK040822
510k NumberK040822
Device Name:LIQUICHEK TORCH PLUS IGM CONTROL
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant BIO-RAD LABORATORIES, INC. 9500 JERONIMO RD. Irvine,  CA  92618 -2017
ContactMaria Keballos
CorrespondentMaria Keballos
BIO-RAD LABORATORIES, INC. 9500 JERONIMO RD. Irvine,  CA  92618 -2017
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-03-30
Decision Date2004-05-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847661000518 K040822 000
00847661000501 K040822 000
00847661000273 K040822 000
00847661000266 K040822 000

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