ONLINE DAT Benzodiazepines II— 510(k) K221765

Name: FDA 510(k) clearance K221765
Creator: U.S. Food and Drug Administration
Published: 2022-12-23

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K221765 for ONLINE DAT Benzodiazepines II, Substantially Equivalent on 2022-12-23. Applicant: Roche Diagnostics. Device class: 2.

Clearance details

Applicant: Roche Diagnostics
Product code: Code JXM
Device class: Class 2
Regulation: 21 CFR 862.3170
Advisory panel: Clinical Toxicology
Date received: 2022-06-17
Decision date: 2022-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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