TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER

Iga, Fitc, Antigen, Antiserum, Control

HELENA LABORATORIES

The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Titan Gel Ife Free Kappa/lamba Light Chain Antiser.

Pre-market Notification Details

Device IDK891683
510k NumberK891683
Device Name:TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER
ClassificationIga, Fitc, Antigen, Antiserum, Control
Applicant HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont,  TX  77704
ContactPat Franks
CorrespondentPat Franks
HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont,  TX  77704
Product CodeCZN  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-03-22
Decision Date1989-04-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M52594220 K891683 000

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