ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05

Calibrator, Multi-analyte Mixture

ELITECHGROUP

The following data is part of a premarket notification filed by Elitechgroup with the FDA for Elitech Clinical Systems Elical 2, Elitech Clinical Systems Elitrol I, Elitech Clinical Systems Elitrol Ii Model Cali-05.

Pre-market Notification Details

Device IDK112029
510k NumberK112029
Device Name:ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05
ClassificationCalibrator, Multi-analyte Mixture
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 CodeJIX  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-07-15
Decision Date2011-08-30
Summary:summary

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