Medical Device Manufacturer · US , San Diego , CA

Biosite Incorporated - FDA 510(k) Cleared Devices

46 submissions · 45 cleared · Since 1990

46

Total

45

Cleared

1

Denied

FDA 510(k) Regulatory Record - Biosite Incorporated Toxicology ✕

14 devices

1-12 of 14

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

Toxicology · 141d