ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT

Anti-rnp 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-sm/rnp Antibody Test Kit.

Pre-market Notification Details

Device IDK940588
510k NumberK940588
Device Name:ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT
ClassificationAnti-rnp Antibody, Antigen And Control
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 CodeLKO  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-02-08
Decision Date1994-04-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847817022456 K940588 000

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