ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL

Calibrator, Secondary

ELITECHGROUP

The following data is part of a premarket notification filed by Elitechgroup with the FDA for Elitech Clinical Systems Urine Total Protein Plus Standard 100 Mg/dl, Elitech Clinical Systems Urine Control Bi-level.

Pre-market Notification Details

Device IDK122177
510k NumberK122177
Device Name:ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL
ClassificationCalibrator, Secondary
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 CodeJIT  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-07-23
Decision Date2013-02-15
Summary:summary

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