Cleared Traditional

S-TEST C-REACTIVE PROTEIN (CRP)

K083040 · Alfa Wassermann Diagnostic Technologies, Inc. · Chemistry
Jan 2009
Decision
108d
Days
Class 2
Risk

About This 510(k) Submission

K083040 is an FDA 510(k) clearance for the S-TEST C-REACTIVE PROTEIN (CRP), a System, Test, C-reactive Protein (Class II — Special Controls, product code DCN), submitted by Alfa Wassermann Diagnostic Technologies, Inc. (West Caldwell, US). The FDA issued a Cleared decision on January 30, 2009, 108 days after receiving the submission on October 14, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number K083040 FDA.gov
FDA Decision Cleared SESE
Date Received October 14, 2008
Decision Date January 30, 2009
Days to Decision 108 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DCN — System, Test, C-reactive Protein
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5270

Similar Devices — DCN System, Test, C-reactive Protein

All 69
CardioPhase? hsCRP
K232624 · Siemens Healthcare Diagnostic Products GmbH · Nov 2023
RCRP Flex reagent cartridge
K221119 · Siemens Healthcare Diagnostics, Inc. · Mar 2023
Tina-quant C-Reactive Protein IV
K192072 · Roche Diagnostics Operations (Rdo) · Feb 2020
Optilite High Sensitivity C-Reactive Protein Kit
K180099 · The Binding Site Group , Ltd. · Oct 2018
Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls
K172868 · The Binding Site Group , Ltd. · Feb 2018
MSD CRP Assay Kit and MESO SECTOR S 700 Instrument
K171498 · Meso Scale Diagnostics, LLC · Jan 2018

More from Alfa Wassermann Diagnostic...

View all
ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT
K131975 · CFJ · Oct 2013
ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT
K123953 · KHS · May 2013
ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE
K123018 · CFR · Apr 2013
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT
K122757 · CHH · Oct 2012
ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT
K113389 · CDN · Aug 2012