THE TURBOX ANALYSER SYSTEM COMPLEMENT C3 AND C4

FDA 510(k)

FDA Class 2 ·Immunology

CLEARBLUE EASY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TURBOX THEOPHYLLINE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ALBUMIN IN URINE

FDA 510(k)

FDA Class 2 ·Immunology

TURBOX RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

CLEARBLUE EASY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ALBUMIN IN SERUM

FDA 510(k)

FDA Class 2 ·Immunology

CLEARVIEW HCG SERUM/URINE PROFESS PREG TEST, MODIF

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OXOID INFECTIOUS MONONUCLEOSIS KIT

FDA 510(k)

FDA Class 2 ·Immunology

HAPTOGLOBIN

FDA 510(k)

FDA Class 2 ·Immunology

IMMUNOGLOBULINS M

FDA 510(k)

FDA Class 2 ·Immunology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK FAMILY PTCA BALLOON CATHETERS, MAVERICK OTW, MAVERICK2 MONORAIL (MR), QUANTUM MAVERICK OTW AND QUANTUM MAVERICK

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS OTW PHOTON CORONARY DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS OTW PHOTON CORONARY DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·FLEXTOME CUTTING BALLOON OTW PTCA CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS OTW SOLARIS CORONARY DILATATION CATHETER

RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER, RX HERCULINK 14 BILIARY STN

FDA 510(k)

FDA Class 2 ·Cardiovascular

MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK OTW CORONARY DILATATION CATHETER (INCLUDIN

FDA 510(k)

FDA Class 2 ·Cardiovascular

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·QUANTUM MAVERICK MONORAIL/OTW PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·APEX MONORAIL & APEX OTW PTCA DILATATION CATHETER/MAVERICK2 MONORAIL PTCA CATHETER/MAVERICK OTW PTCA CATHETER/MAVERICK