Biosite Incorporated - FDA 510(k) Cleared Devices
46
Total
45
Cleared
1
Denied
46 devices
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
Mar 16, 2001
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000
Chemistry
46d
Not Cleared
Nov 20, 2000
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
Chemistry
5d
Cleared
Mar 02, 2000
TRIAGE BNP CALIBRATION VERIFICATION CONTROLS
Chemistry
35d
Cleared
Feb 29, 2000
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) CONTROLS
Chemistry
33d
Cleared
Oct 06, 1998
TRIAGE,PARASITE PANEL, TRIAGE CRYPTOSPORIDIUM AND ENTAMOEBA HISTOLYTICA,...
Microbiology
102d
Cleared
Mar 20, 1998
TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A
Microbiology
80d
Cleared
Jan 13, 1998
TRIAGE STATMETER
Chemistry
117d
Cleared
Jan 08, 1998
TRIAGE(R) CARDIAC PANEL CALIBRATION VERIFICATION CONTROLS, TRIAG (R)...
Chemistry
15d
Cleared
Dec 10, 1997
TRIAGE CARDIAC CONTROLS, TRIAGE TROPONIN-I CONTROL, TRIAGE CK-MB CONTROL,...
Chemistry
15d
Cleared
Dec 03, 1997
TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER...
Toxicology
61d
Cleared
Oct 06, 1997
TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN,...
Chemistry
47d
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