Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge

C-reactive Protein, Antigen, Antiserum, And Control

Procise Diagnostics

The following data is part of a premarket notification filed by Procise Diagnostics with the FDA for Procise Crp, Procisedx Analyzer, Procisedx Calibration Cartridge.

Pre-market Notification Details

Device IDK201256
510k NumberK201256
Device Name:Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge
ClassificationC-reactive Protein, Antigen, Antiserum, And Control
Applicant Procise Diagnostics 9449 Carroll Park Drive San Diego,  CA  92121
ContactDan Kiser
CorrespondentKurtis Bray
Procise Diagnostics 9449 Carroll Park Drive San Diego,  CA  92121
Product CodeDCK  
CFR Regulation Number866.5270 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-11
Decision Date2022-11-04

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