TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 3067

Gamma Globulin, Antigen, Antiserum, Control

HELENA LABORATORIES

The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Titan Gel Immunofix-9 Cat. No. 3051 And 3067.

Pre-market Notification Details

Device IDK931247
510k NumberK931247
Device Name:TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 3067
ClassificationGamma Globulin, 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 CodeDAH  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-03-11
Decision Date1993-04-27

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