TRIAGE PANEL FOR DRUGS OF ABUSE/TRICYCLIC ANTIDEPRESSANTS— 510(k) K955935

Name: FDA 510(k) clearance K955935
Creator: U.S. Food and Drug Administration
Published: 1996-02-15

Substantially Equivalent

Biosite Incorporated

FDA 510(k) clearance K955935 for TRIAGE PANEL FOR DRUGS OF ABUSE/TRICYCLIC ANTIDEPRESSANTS, Substantially Equivalent on 1996-02-15. Applicant: Biosite Incorporated. Device class: 2.

Clearance details

Applicant: Biosite Incorporated
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 1995-12-13
Decision date: 1996-02-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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