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FDA 510(k)

ONLINE DAT BARBITURATES PLUS

K-Number: K043211 · 2004-12-29

ApplicantRoche Diagnostics Corp.
Decision Date2004-12-29
Product CodeDIS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ONLINE DAT BARBITURATES PLUS 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 2004-12-29 under 510(k) number K043211. The device is classified under product code DIS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONLINE DAT BARBITURATES PLUS?

ONLINE DAT BARBITURATES PLUS is a medical device that received FDA 510(k) clearance on 2004-12-29. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K043211.

When did ONLINE DAT BARBITURATES PLUS receive FDA 510(k) clearance?

ONLINE DAT BARBITURATES PLUS received FDA 510(k) clearance on 2004-12-29, under 510(k) number K043211.

Who is the listed applicant for ONLINE DAT BARBITURATES PLUS?

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 ONLINE DAT BARBITURATES PLUS?

The FDA product code for ONLINE DAT BARBITURATES PLUS is DIS.

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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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