INSTANT-VIEW METHAMPHETAMINE URINE DIP STRIP TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

OralTox Oral Fluid Drug Test

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

OralTox Oral fluid Drug Test

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use, BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

KIDNEY, ARTIFICIAL, C-DAK 1.5

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

A-V FISTULA NEEDLE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

KIDNEY, ARTIFICIAL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

RAPIDONE-ECSTASY TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE 500 DRUG SCREEN TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BANDAGE, COMPRESSION, FISTULAID

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Integrity V500 (Integrity, Integrity with VEMP)

FDA 510(k)

FDA Class 2 ·Neurology

VIVOSONIC NEUROSCREEN

FDA 510(k)

FDA Class 2 ·Neurology

SAM CRRT Unit, SAM Cassette CRRT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Endotoxin Activity Assay (EAA)

FDA 510(k)

FDA Class 2 ·Microbiology

SPECTRAL WEST NILE VIRUS IGM STATUS TEST

FDA 510(k)

FDA Class 2 ·Microbiology

ProCell Surgical Sponge-Blood Recovery Unit

FDA 510(k)

FDA Class 2 ·Anesthesiology

oCare Wrist Pulse Oximeter

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular