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FDA 510(k)

TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM

K-Number: K072714 · 2008-04-18

ApplicantRoche Diagnostics Corp.
Decision Date2008-04-18
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2008-04-18 under 510(k) number K072714. 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 TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM?

TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2008-04-18. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K072714.

When did TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM receive FDA 510(k) clearance?

TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM received FDA 510(k) clearance on 2008-04-18, under 510(k) number K072714.

Who is the listed applicant for TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM?

The FDA 510(k) record lists Roche Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM?

The FDA product code for TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM 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.

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