BIOSITE DIAGNOSTICS OPIATE SCREENING TEST— 510(k) K902924

Name: FDA 510(k) clearance K902924
Creator: U.S. Food and Drug Administration
Published: 1990-09-14

Substantially Equivalent

Biosite Incorporated

FDA 510(k) clearance K902924 for BIOSITE DIAGNOSTICS OPIATE SCREENING TEST, Substantially Equivalent on 1990-09-14. Applicant: Biosite Incorporated. Device class: 2.

Clearance details

Applicant: Biosite Incorporated
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 1990-07-02
Decision date: 1990-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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