ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST

Extractable Antinuclear Antibody, Antigen And Control

HELIX DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Helix Diagnostics, Inc. with the FDA for Enzyme Immunoassay Anti-centromere Antibody Test.

Pre-market Notification Details

Device IDK000489
510k NumberK000489
Device Name:ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST
ClassificationExtractable Antinuclear Antibody, Antigen And Control
Applicant HELIX DIAGNOSTICS, INC. 3148 INDUSTRIAL BLVD. West Sacramento,  CA  95691 -6221
ContactVirginia Cappel
CorrespondentVirginia Cappel
HELIX DIAGNOSTICS, INC. 3148 INDUSTRIAL BLVD. West Sacramento,  CA  95691 -6221
Product CodeLLL  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-02-14
Decision Date2000-04-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847817022340 K000489 000

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