CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST)

Enzymatic Esterase--oxidase, Cholesterol

TRACE SCIENTIFIC LTD.

The following data is part of a premarket notification filed by Trace Scientific Ltd. with the FDA for Cholesterol-incorporating Dynamic Stab Tech (dst).

Pre-market Notification Details

Device IDK962890
510k NumberK962890
Device Name:CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST)
ClassificationEnzymatic Esterase--oxidase, Cholesterol
Applicant TRACE SCIENTIFIC LTD. 7260 NORTH WEST 58TH ST. Miami,  FL  33166
ContactDavid Johnston
CorrespondentDavid Johnston
TRACE SCIENTIFIC LTD. 7260 NORTH WEST 58TH ST. Miami,  FL  33166
Product CodeCHH  
CFR Regulation Number862.1175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-07-24
Decision Date1996-09-27

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