EMDS ALBUMIN (ALB) TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

EMDS ALKANINE PHOSPHATASE (ALP) TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI PROBE III BALLOON-ON-A-WIRE DILATATION SYSTEM

COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MORPHINE ROCHE (R) EIA TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

REVISED LABELING FOR BENZODIAZEPINE TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

REVISED LABELING FOR COCAINE/COCAINE META. TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ROCHE REAGENT FOR CHLORIDE, FOR THE COBAS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ION-SPECIFIC ELECTRODE OPTION FOR COBAS FARA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

REVISED LABELING FOR LSD TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ABUSCREEN (R) EIA BARBITURATE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology