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FDA 510(k)

ONLINE DAT Benzodiazepines II

K-Number: K221765 · 2022-12-23

ApplicantRoche Diagnostics
Decision Date2022-12-23
Product CodeJXM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ONLINE DAT Benzodiazepines II is a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2022-12-23 under approval 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. It is manufactured by Roche Diagnostics. The 510(k) number is K221765.

When was ONLINE DAT Benzodiazepines II approved by the FDA?

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

What company makes ONLINE DAT Benzodiazepines II?

ONLINE DAT Benzodiazepines II is manufactured by Roche Diagnostics.

What is the FDA product code for ONLINE DAT Benzodiazepines II?

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

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Related Devices (Code: 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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