BIOSITE DIAGNOSTICS-TRIAGE PANEL FOR DRUGS ABUSE— 510(k) K914146

Name: FDA 510(k) clearance K914146
Creator: U.S. Food and Drug Administration
Published: 1991-10-11

Substantially Equivalent

Biosite Incorporated

FDA 510(k) clearance K914146 for BIOSITE DIAGNOSTICS-TRIAGE PANEL FOR DRUGS ABUSE, Substantially Equivalent on 1991-10-11. 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: 1991-09-16
Decision date: 1991-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DKZ

view all

K240670 — DRI Ecstasy Plus Assay2024-10-30
K233019 — AllTest Multi-Drug Rapid Test Cup +3 more2023-12-13
K231137 — Xenta Drug Screen Cup, Xenta Drug Screen Dipcard2023-05-19
K200363 — Quidel Triage® TOX Drug Screen, 946002020-03-11
K191099 — Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel2019-10-03

More clearances from Biosite Incorporated

view all

K092987 — INRATIO/INRATIO2 TEST STRIPS2010-06-11
K092048 — ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP2010-04-19
K093032 — TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET2009-11-13
K080269 — TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS2008-06-06
K072892 — TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 52007-12-07

Data sourced from openFDA. This site is unofficial and independent of the FDA.