FDA 510(k)

TQ HBA1C GEN3

K-Number: K102914 · 2011-01-20

ApplicantRoche

Decision Date2011-01-20

Product CodeLCP

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

TQ HBA1C GEN3 is the device name listed in this FDA 510(k) record. The listed applicant is Roche. It received FDA 510(k) clearance on 2011-01-20 under 510(k) number K102914. 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 TQ HBA1C GEN3?

TQ HBA1C GEN3 is a medical device that received FDA 510(k) clearance on 2011-01-20. The listed applicant is Roche. The 510(k) number is K102914.

When did TQ HBA1C GEN3 receive FDA 510(k) clearance?

TQ HBA1C GEN3 received FDA 510(k) clearance on 2011-01-20, under 510(k) number K102914.

Who is the listed applicant for TQ HBA1C GEN3?

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

What is the FDA product code for TQ HBA1C GEN3?

The FDA product code for TQ HBA1C GEN3 is LCP.

Other records listing Roche as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K113793HOMOCYSTEINE TEST

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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.