Biosite Incorporated - FDA 510(k) Cleared Devices
Recent clearances: INRATIO/INRATIO2 TEST STRIPS, ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP, TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET
46
Total
45
Cleared
1
Denied
FDA 510(k) Regulatory Record - Biosite Incorporated Toxicology ✕
14 devices
Cleared
Jun 22, 2006
TRIAGE TOX DRUG SCREEN, MODEL 94400
Toxicology
91d
Cleared
Feb 28, 2005
TRIAGE TOX DRUG SCREEN
Toxicology
97d
Cleared
Jun 03, 2002
TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002
Toxicology
159d
Cleared
Jan 10, 2002
TRIAGE TOX DRUG SCREEN, CATALOG #94000
Toxicology
147d
Cleared
Oct 03, 2001
TRIAGE TOX DRUG SCREEN CONTROLS, CATALOG #94001
Toxicology
27d
Cleared
Oct 03, 2001
TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #94002
Toxicology
27d
Cleared
Dec 03, 1997
TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER...
Toxicology
61d
Cleared
Feb 16, 1996
TRIAGE PANEL FOR DRUGS OF ABUSE MODEL 9500/93000
Toxicology
65d
Cleared
Feb 15, 1996
TRIAGE PANEL FOR DRUGS OF ABUSE/TRICYCLIC ANTIDEPRESSANTS
Toxicology
64d
Cleared
Dec 02, 1994
BIOSITE DIAGNOSTICS - TRIAGE PANEL FOR DRUGS OF ABUSE PLUS TRICYCLIC...
Toxicology
450d
Cleared
May 12, 1993
BIOSITE TRIAGE PANEL FOR DRUGS OF ABUSE(50NG/ML)
Toxicology
41d
Cleared
Jan 22, 1993
THE TRIAGE II
Toxicology
141d
Cleared
Oct 11, 1991
BIOSITE DIAGNOSTICS-TRIAGE PANEL FOR DRUGS ABUSE
Toxicology
25d
Cleared
Sep 14, 1990
BIOSITE DIAGNOSTICS OPIATE SCREENING TEST
Toxicology
74d