FDA 510(k)

ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72

K-Number: K063306 · 2007-04-17

Decision Date2007-04-17

Product CodeLCP

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72 is the device name listed in this FDA 510(k) record. The listed applicant is Alfa Wassermann, Inc.. It received FDA 510(k) clearance on 2007-04-17 under 510(k) number K063306. 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 A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72?

ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72 is a medical device that received FDA 510(k) clearance on 2007-04-17. The listed applicant is Alfa Wassermann, Inc.. The 510(k) number is K063306.

When did ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72 receive FDA 510(k) clearance?

ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72 received FDA 510(k) clearance on 2007-04-17, under 510(k) number K063306.

Who is the listed applicant for ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72?

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

What is the FDA product code for ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72?

The FDA product code for ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72 is LCP.

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Official Source

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