TRIAGE TOX DRUG SCREEN CONTROLS— 510(k) K050037

Substantially Equivalent

Biosite Incorporated

FDA 510(k) clearance K050037 for TRIAGE TOX DRUG SCREEN CONTROLS, Substantially Equivalent on 2005-03-22. Applicant: Biosite Incorporated. Device class: 1.

Clearance details

Applicant
Biosite Incorporated
Product code
Code DIF
Device class
Class 1
Regulation
21 CFR 862.3280
Advisory panel
Clinical Toxicology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Diego, CA, US
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