FDA 510(k)

ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT

K-Number: K131488 · 2013-08-19

ApplicantAlfa Wassermann Diagnostics Technologies, LLC

Decision Date2013-08-19

Product CodeCIX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Alfa Wassermann Diagnostics Technologies, LLC. It received FDA 510(k) clearance on 2013-08-19 under 510(k) number K131488. The device is classified under product code CIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT?

ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT is a medical device that received FDA 510(k) clearance on 2013-08-19. The listed applicant is Alfa Wassermann Diagnostics Technologies, LLC. The 510(k) number is K131488.

When did ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT receive FDA 510(k) clearance?

ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT received FDA 510(k) clearance on 2013-08-19, under 510(k) number K131488.

Who is the listed applicant for ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT?

The FDA 510(k) record lists Alfa Wassermann Diagnostics Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT?

The FDA product code for ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT is CIX.

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Other records listing Alfa Wassermann Diagnostics Technologies, LLC as applicant

K123322ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT K122302ACE MAGNESIUM REGENT

Related Devices (Code: CIX)

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Official Source

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