LIQUICHEK ANTI-MITOTIC SPINDLE PATTERN CONTROL, POSITIVE, CATALOG #118

Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

BIO-RAD

The following data is part of a premarket notification filed by Bio-rad with the FDA for Liquichek Anti-mitotic Spindle Pattern Control, Positive, Catalog #118.

Pre-market Notification Details

Device IDK024231
510k NumberK024231
Device Name:LIQUICHEK ANTI-MITOTIC SPINDLE PATTERN CONTROL, POSITIVE, CATALOG #118
ClassificationAntinuclear Antibody, Indirect Immunofluorescent, 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 CodeDHN  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-12-23
Decision Date2003-01-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847661000129 K024231 000

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