FDA 510(k)

ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT

K-Number: K113437 · 2012-08-06

ApplicantAlfa Wassermann Diagnostic Technologies, Inc.

Decision Date2012-08-06

Product CodeLCP

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Alfa Wassermann Diagnostic Technologies, Inc.. It received FDA 510(k) clearance on 2012-08-06 under 510(k) number K113437. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT?

ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT is a medical device that received FDA 510(k) clearance on 2012-08-06. The listed applicant is Alfa Wassermann Diagnostic Technologies, Inc.. The 510(k) number is K113437.

When did ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT receive FDA 510(k) clearance?

ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT received FDA 510(k) clearance on 2012-08-06, under 510(k) number K113437.

Who is the listed applicant for ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT?

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

What is the FDA product code for ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT?

The FDA product code for ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT is LCP.

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Other records listing Alfa Wassermann Diagnostic Technologies, Inc. as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.