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FDA 510(k)

COBAS INTEGRA ONLINE DAT II COCAINE II

K-Number: K023296 · 2002-11-25

ApplicantRoche Diagnostics Corp.
Decision Date2002-11-25
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

COBAS INTEGRA ONLINE DAT II COCAINE II 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 2002-11-25 under 510(k) number K023296. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBAS INTEGRA ONLINE DAT II COCAINE II?

COBAS INTEGRA ONLINE DAT II COCAINE II is a medical device that received FDA 510(k) clearance on 2002-11-25. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K023296.

When did COBAS INTEGRA ONLINE DAT II COCAINE II receive FDA 510(k) clearance?

COBAS INTEGRA ONLINE DAT II COCAINE II received FDA 510(k) clearance on 2002-11-25, under 510(k) number K023296.

Who is the listed applicant for COBAS INTEGRA ONLINE DAT II COCAINE II?

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 ONLINE DAT II COCAINE II?

The FDA product code for COBAS INTEGRA ONLINE DAT II COCAINE II is DIO.

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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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