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FDA 510(k)

TINA-QUANT HBA1C GEN.2

K-Number: K110313 · 2011-12-23

ApplicantRoche Diagnostics
Decision Date2011-12-23
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

TINA-QUANT HBA1C GEN.2 is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2011-12-23 under 510(k) number K110313. 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 HBA1C GEN.2?

TINA-QUANT HBA1C GEN.2 is a medical device that received FDA 510(k) clearance on 2011-12-23. The listed applicant is Roche Diagnostics. The 510(k) number is K110313.

When did TINA-QUANT HBA1C GEN.2 receive FDA 510(k) clearance?

TINA-QUANT HBA1C GEN.2 received FDA 510(k) clearance on 2011-12-23, under 510(k) number K110313.

Who is the listed applicant for TINA-QUANT HBA1C GEN.2?

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

What is the FDA product code for TINA-QUANT HBA1C GEN.2?

The FDA product code for TINA-QUANT HBA1C GEN.2 is LCP.

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Related Devices (Code: 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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