ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT

Antinuclear Antibody (enzyme-labeled), Antigen, Controls

HELIX DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Helix Diagnostics, Inc. with the FDA for Enzyme Immunoassay Anti-jo-1 Antibody Test Kit.

Pre-market Notification Details

Device IDK951850
510k NumberK951850
Device Name:ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT
ClassificationAntinuclear Antibody (enzyme-labeled), Antigen, Controls
Applicant HELIX DIAGNOSTICS, INC. 3148 INDUSTRIAL BLVD. West Sacramento,  CA  95691 -6221
ContactVirginia L Cappel
CorrespondentVirginia L Cappel
HELIX DIAGNOSTICS, INC. 3148 INDUSTRIAL BLVD. West Sacramento,  CA  95691 -6221
Product CodeLJM  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-21
Decision Date1995-07-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847817022401 K951850 000

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