WAKO(TM) AUTOKIT LDH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

WAKO(TM) AUTOKIT TOTAL PROTEIN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LONGY Implant and LONGY-N Implant

FDA 510(k)

FDA Class 2 ·Dental

URIC ACID STANDARD SOLUTION CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP,BIOSIGN DOA 10, BIOSIGN MET/OPI/COC/

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

COA-COMP/M, AUTOMATED BIPOLAR COAGULATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

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

Chemtrue Multi-Panel DOA DIP Card Tests

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LIFESIGN DOA 4 (THC/OPI/COC/MET)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MODEL CBC-1 COA COMP ANTI-STICKING BIPOLAR COAG.

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODEL CBC-1 COA-COMP ANTI-STICKING BIOPOLAR COAG.

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

HEMACON-DOA(TM) DRUGS OF ABUSE WHOLE BLOOD CONTROL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

HEARTSTART 2000, MANUAL DEFIBRILLATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular