LIQUICHEK ANTI-SCL-70 CONTROL, POSITIVE, CATALOG #116

Antinuclear Antibody, Antigen, Control

BIO-RAD

The following data is part of a premarket notification filed by Bio-rad with the FDA for Liquichek Anti-scl-70 Control, Positive, Catalog #116.

Pre-market Notification Details

Device IDK024226
510k NumberK024226
Device Name:LIQUICHEK ANTI-SCL-70 CONTROL, POSITIVE, CATALOG #116
ClassificationAntinuclear Antibody, Antigen, Control
Applicant BIO-RAD 9500 JERONIMO RD. Irvine,  CA  92618 -2017
ContactYvette Lloyd
CorrespondentYvette Lloyd
BIO-RAD 9500 JERONIMO RD. Irvine,  CA  92618 -2017
Product CodeLKJ  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-12-23
Decision Date2003-01-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847661000174 K024226 000

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