STREPTEX DIRECT A ZL14

Antisera, All Groups, Streptococcus Spp.

WELLCOME DIAGNOSTICS

The following data is part of a premarket notification filed by Wellcome Diagnostics with the FDA for Streptex Direct A Zl14.

Pre-market Notification Details

Device IDK842827
510k NumberK842827
Device Name:STREPTEX DIRECT A ZL14
ClassificationAntisera, All Groups, Streptococcus Spp.
Applicant WELLCOME DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGTZ  
CFR Regulation Number866.3740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-07-20
Decision Date1984-08-16

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