DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI

Alpha-naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes

SIEMENS HEALTHCARE DIAGNOSTICS

The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Dimension Vista Alkaline Phosphatase (alpi) Flex Reagent Cartridge Dimension Vista Alkaline Phosphatase Calibrator (alpi.

Pre-market Notification Details

Device IDK122323
510k NumberK122323
Device Name:DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI
ClassificationAlpha-naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes
Applicant SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE MS 514 Newark,  DE  19702
ContactRose T Marinelli
CorrespondentRose T Marinelli
SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE MS 514 Newark,  DE  19702
Product CodeCJO  
CFR Regulation Number862.1050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-01
Decision Date2012-08-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842768039041 K122323 000
00842768039034 K122323 000
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