ASCA-CHEK

Antibodies, Saccharomyces Cerevisiae (s.cerevisiae)

TECHLAB INC., CORPORATE RESEARCH CENTER

The following data is part of a premarket notification filed by Techlab Inc., Corporate Research Center with the FDA for Asca-chek.

Pre-market Notification Details

Device IDK071711
510k NumberK071711
Device Name:ASCA-CHEK
ClassificationAntibodies, Saccharomyces Cerevisiae (s.cerevisiae)
Applicant TECHLAB INC., CORPORATE RESEARCH CENTER 2001 KRAFT DR. Blacksburg,  VA  24060 -6358
ContactCharles Pennington
CorrespondentCharles Pennington
TECHLAB INC., CORPORATE RESEARCH CENTER 2001 KRAFT DR. Blacksburg,  VA  24060 -6358
Product CodeNBT  
CFR Regulation Number866.5785 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-06-22
Decision Date2007-11-07
Summary:summary

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