CEDIA DAU BENZODIAZEPINE ASSAY— 510(k) K962734

Name: FDA 510(k) clearance K962734
Creator: U.S. Food and Drug Administration
Published: 1996-12-10

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K962734 for CEDIA DAU BENZODIAZEPINE ASSAY, Substantially Equivalent on 1996-12-10. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code JXM
Device class: Class 2
Regulation: 21 CFR 862.3170
Advisory panel: Clinical Toxicology
Date received: 1996-07-15
Decision date: 1996-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

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