FDA 510(k)

ONLINE DAT Benzodiazepines II

K-Number: K221765 · 2022-12-23

Decision Date2022-12-23

Product CodeJXM

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

ONLINE DAT Benzodiazepines II is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2022-12-23 under 510(k) number K221765. 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 II?

ONLINE DAT Benzodiazepines II is a medical device that received FDA 510(k) clearance on 2022-12-23. The listed applicant is Roche Diagnostics. The 510(k) number is K221765.

When did ONLINE DAT Benzodiazepines II receive FDA 510(k) clearance?

ONLINE DAT Benzodiazepines II received FDA 510(k) clearance on 2022-12-23, under 510(k) number K221765.

Who is the listed applicant for ONLINE DAT Benzodiazepines II?

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 ONLINE DAT Benzodiazepines II?

The FDA product code for ONLINE DAT Benzodiazepines II is JXM.

Other records listing Roche Diagnostics as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.