TRIAGE TOX DRUG SCREEN, CATALOG #94000— 510(k) K012745

Name: FDA 510(k) clearance K012745
Creator: U.S. Food and Drug Administration
Published: 2002-01-10

Substantially Equivalent

Biosite Incorporated

FDA 510(k) clearance K012745 for TRIAGE TOX DRUG SCREEN, CATALOG #94000, Substantially Equivalent on 2002-01-10. 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: 2001-08-16
Decision date: 2002-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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