Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)

Enzyme Immunoassay, Tracrolimus

SIEMENS HEALTHCARE DIAGNOSTICS

The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Dimension Tacrolimus Flex® Reagent Cartridge (tac), Dimension Tacrolimus Calibrator (tac Cal).

Pre-market Notification Details

Device IDK150168
510k NumberK150168
Device Name:Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)
ClassificationEnzyme Immunoassay, Tracrolimus
Applicant SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE Newark,  DE  19714
ContactAnna Marie Kathleen Ennis
CorrespondentKathleen Dray-lyons
SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE Newark,  DE  19714
Product CodeMLM  
CFR Regulation Number862.1678 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-01-26
Decision Date2015-11-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842768035432 K150168 000
00842768035425 K150168 000

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