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FDA 510(k)

COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY

K-Number: K092603 · 2009-12-04

ApplicantRoche Diagnostics
Decision Date2009-12-04
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2009-12-04 under 510(k) number K092603. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY?

COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY is a medical device that received FDA 510(k) clearance on 2009-12-04. The listed applicant is Roche Diagnostics. The 510(k) number is K092603.

When did COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY receive FDA 510(k) clearance?

COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY received FDA 510(k) clearance on 2009-12-04, under 510(k) number K092603.

Who is the listed applicant for COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY?

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 COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY?

The FDA product code for COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY is CFR.

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Related Devices (Code: CFR)

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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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