GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT

Helicobacter Pylori

GOLD STANDARD DIAGNOSTICS

The following data is part of a premarket notification filed by Gold Standard Diagnostics with the FDA for Gold Standard Diagnostics H. Pylori Elisa Iga Test Kit.

Pre-market Notification Details

Device IDK110899
510k NumberK110899
Device Name:GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT
ClassificationHelicobacter Pylori
Applicant GOLD STANDARD DIAGNOSTICS 2851 SPAFFORD Davis,  CA  95618
ContactNapoleon Monce
CorrespondentNapoleon Monce
GOLD STANDARD DIAGNOSTICS 2851 SPAFFORD Davis,  CA  95618
Product CodeLYR  
CFR Regulation Number866.3110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-03-30
Decision Date2012-02-01
Summary:summary

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