Ace Carbon Dioxide Reagent, Ace Direct Biliubin Reagent, Ace Total Bilirubin Reagent, Ace Magnesium Reagent

FDA 510(k) K123953 · Alfa Wassermann Diagnostic Technologies, Inc.

Substantially Equivalent

510(k) numberK123953

Submission

Device name
Ace Carbon Dioxide Reagent, Ace Direct Biliubin Reagent, Ace Total Bilirubin Reagent, Ace Magnesium Reagent
Applicant
Alfa Wassermann Diagnostic Technologies, Inc.
West Caldwell, NJ, US
Received
December 21, 2012
Decision date
May 2, 2013
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KHS – Enzymatic, Carbon-Dioxide
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1160
Specialty
Clinical Chemistry

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K140248S Test Reagent Cartridge Carbon Dioxide (CO2)KHS · Traditional Hitachi Chemical Diagnostics, Inc.03/11/2014SE
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K120765Vitros Chemistry Products ECO2 SlidesKHS · Special Ortho-Clinical Diagnostics, Inc.10/24/2012SE
K113435Ace Carbon DIOXIDE(CO2-LC) Reagent, Ace Direct Bilirubin Reagent, Ace Total Bilirubin…KHS · Traditional Alfa Wassermann07/02/2012SE
K111960Elitech Clinical Systems Carbon Dioxide Electrode, Elitech Clinical Systems Ise…KHS · Traditional Elitechgroup11/18/2011SE
K100060Eon 100 Chemistry Analyzer with Ise , Model 77105, Bicarbonate Reagent, Model 77475KHS · Traditional Vital Diagnostics (Manufacturing) Ptyltd12/15/2010SE
K100289Advia Chemistry Systems Carbon Dioxide Liquid (C02_L) Assay, Model Ref 07987100, 07506781KHS · Traditional Siemens Healthcare Diagnostics05/10/2010SE
K093611Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products DT Calibrator Kit…KHS · Traditional Ortho-Clinical Diagnostics, Inc.04/15/2010SE

More from Ortho-Clinical Diagnostics, Inc.

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K170623ACE Hemoglobin A1c (HbA1c) ReagentLCP · Traditional 02/27/2018SE
K131975Ace Direct Total Iron-Binding Capacity (Tibc) Reagent, Ace Total Iron Reagent, Ace Ldh-L…CFJ · Traditional 10/02/2013SE
K131351Ace Alkaline Phosphatase Reagent, Amylase Reagent, Alt Reagent, Ast ReagentCJE · Traditional 08/15/2013SE
K123018Ace Alera Clinical Chemistry System, Ace Glucose Reagent, Ace Ion Selective Electrode…CFR · Traditional 04/23/2013SE
K122757Ace Cholesterol Reagent, Ace Hdl-C Reagent, Ace Ldl-C Reagent, Ace Triglycerides ReagentCHH · Traditional 10/05/2012SE
K113389Ace CK Reagent,Ace Bun/Urea Reagent,Ace Uric Acid Reagent,Ace Creatinine ReagentCDN · Traditional 08/10/2012SE
K113437Ace Hemoglobin Alc(Hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace T4 Reagent, Ace…LCP · Traditional 08/06/2012SE
K113374Ace Albumin Reagent Ace Total Protein Reagent Ace Calcium-Arsenazo Reagent Ace…CIX · Traditional 07/13/2012SE
K113262Ace Cholesterol Reagent, Ace Hdl-C Reagent, Ace Ldl-C Reagent-C, Ace-Trislycerides ReagentCHH · Traditional 07/03/2012SE
K113438Ace Direct Totaliron-Binding Capacity (Tibc) Reagent, Ace Serum Iron Reagent, Ace Lipase…JMO · Traditional 06/01/2012SE

Questions and answers

When was Ace Carbon Dioxide Reagent, Ace Direct Biliubin Reagent, Ace Total Bilirubin Reagent, Ace Magnesium Reagent cleared by the FDA?

Ace Carbon Dioxide Reagent, Ace Direct Biliubin Reagent, Ace Total Bilirubin Reagent, Ace Magnesium Reagent (K123953) received a 510(k) decision of Substantially Equivalent on May 2, 2013, 132 days after the submission was received.

What is the product code of K123953?

The FDA product code is KHS – Enzymatic, Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 862.1160.