ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT

U.v. Method, Cpk Isoenzymes

ELITECHGROUP

The following data is part of a premarket notification filed by Elitechgroup with the FDA for Elitech Clinical Systems Envoy 500 Ck Reagent Kit.

Pre-market Notification Details

Device IDK141265
510k NumberK141265
Device Name:ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT
ClassificationU.v. Method, Cpk Isoenzymes
Applicant ELITECHGROUP 21720 23RD DR SE SUITE 150 Bothell,  WA  98021
ContactDebra K Hutson
CorrespondentDebra K Hutson
ELITECHGROUP 21720 23RD DR SE SUITE 150 Bothell,  WA  98021
Product CodeJHW  
CFR Regulation Number862.1215 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-05-15
Decision Date2014-07-18
Summary:summary

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