BIOSITE DIAGNOSTICS - TRIAGE PANEL FOR DRUGS OF ABUSE PLUS TRICYCLIC ANTIDEPRESSANTS— 510(k) K934340

Name: FDA 510(k) clearance K934340
Creator: U.S. Food and Drug Administration
Published: 1994-12-02

Substantially Equivalent

Biosite Incorporated

FDA 510(k) clearance K934340 for BIOSITE DIAGNOSTICS - TRIAGE PANEL FOR DRUGS OF ABUSE PLUS TRICYCLIC ANTIDEPRESSANTS, Substantially Equivalent on 1994-12-02. Applicant: Biosite Incorporated. Device class: 2.

Clearance details

Applicant: Biosite Incorporated
Product code: Code LFI
Device class: Class 2
Regulation: 21 CFR 862.3910
Advisory panel: Clinical Toxicology
Date received: 1993-09-08
Decision date: 1994-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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