FDA 510(k)

S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023

K-Number: K091711 · 2009-12-11

ApplicantAlfa Wassermann Diagnostic Technologies, Inc.

Decision Date2009-12-11

Product CodeLCP

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023 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 2009-12-11 under 510(k) number K091711. 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 S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023?

S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023 is a medical device that received FDA 510(k) clearance on 2009-12-11. The listed applicant is Alfa Wassermann Diagnostic Technologies, Inc.. The 510(k) number is K091711.

When did S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023 receive FDA 510(k) clearance?

S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023 received FDA 510(k) clearance on 2009-12-11, under 510(k) number K091711.

Who is the listed applicant for S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023?

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 S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023?

The FDA product code for S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023 is LCP.

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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.