Ace Albumin Reagent, Ace Total Protein Reagent, Ace Calcium-Arsenazo Reagent and Ace Phosphorus Reagent

FDA 510(k) K131488 · Alfa Wassermann Diagnostics Technologies, LLC

Substantially Equivalent

510(k) numberK131488

Submission

Device name
Ace Albumin Reagent, Ace Total Protein Reagent, Ace Calcium-Arsenazo Reagent and Ace Phosphorus Reagent
Applicant
Alfa Wassermann Diagnostics Technologies, LLC
West Caldwell, NJ, US
Received
May 23, 2013
Decision date
August 19, 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
CIX – Bromcresol Green Dye-Binding, Albumin
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1035
Specialty
Clinical Chemistry

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Questions and answers

When was Ace Albumin Reagent, Ace Total Protein Reagent, Ace Calcium-Arsenazo Reagent and Ace Phosphorus Reagent cleared by the FDA?

Ace Albumin Reagent, Ace Total Protein Reagent, Ace Calcium-Arsenazo Reagent and Ace Phosphorus Reagent (K131488) received a 510(k) decision of Substantially Equivalent on August 19, 2013, 88 days after the submission was received.

What is the product code of K131488?

The FDA product code is CIX – Bromcresol Green Dye-Binding, Albumin, a Class II (moderate risk) device regulated under 21 CFR 862.1035.