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FDA 510(k)

ONLINE DAT BENZODIAZEPINES PLUS

K-Number: K043327 · 2005-02-07

ApplicantRoche Diagnostics Corp.
Decision Date2005-02-07
Product CodeJXM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ONLINE DAT BENZODIAZEPINES 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 2005-02-07 under 510(k) number K043327. The device is classified under product code JXM. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONLINE DAT BENZODIAZEPINES PLUS?

ONLINE DAT BENZODIAZEPINES PLUS is a medical device that received FDA 510(k) clearance on 2005-02-07. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K043327.

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

ONLINE DAT BENZODIAZEPINES PLUS received FDA 510(k) clearance on 2005-02-07, under 510(k) number K043327.

Who is the listed applicant for ONLINE DAT BENZODIAZEPINES 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 BENZODIAZEPINES PLUS?

The FDA product code for ONLINE DAT BENZODIAZEPINES PLUS is JXM.

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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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