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FDA 510(k)

COBAS INTEGRA CHLORIDE ELCTRODE GEN.2

K-Number: K060108 · 2006-02-16

ApplicantRoche Diagnostics Corp.
Decision Date2006-02-16
Product CodeCGZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COBAS INTEGRA CHLORIDE ELCTRODE GEN.2 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 2006-02-16 under 510(k) number K060108. The device is classified under product code CGZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBAS INTEGRA CHLORIDE ELCTRODE GEN.2?

COBAS INTEGRA CHLORIDE ELCTRODE GEN.2 is a medical device that received FDA 510(k) clearance on 2006-02-16. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K060108.

When did COBAS INTEGRA CHLORIDE ELCTRODE GEN.2 receive FDA 510(k) clearance?

COBAS INTEGRA CHLORIDE ELCTRODE GEN.2 received FDA 510(k) clearance on 2006-02-16, under 510(k) number K060108.

Who is the listed applicant for COBAS INTEGRA CHLORIDE ELCTRODE GEN.2?

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 COBAS INTEGRA CHLORIDE ELCTRODE GEN.2?

The FDA product code for COBAS INTEGRA CHLORIDE ELCTRODE GEN.2 is CGZ.

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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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