BILATERAL IMPEDANCE PLETHYSMOGRAPH, BIP(TM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

AIP INTENSE PULSED LIGHT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BETA-POWDER

FDA 510(k)

FDA Class 2 ·Dental

Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MANAN ADAPTER FOR BIP BIOPSY DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DIP/U.S. Urine Analysis Test System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

OptoMonitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

BD MAX Vaginal Panel

FDA 510(k)

FDA Class 2 ·Microbiology

S2 Pigment Removal System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BD MAX Vaginal Panel, BD MAX Instrument

FDA 510(k)

FDA Class 2 ·Microbiology

OptoMonitor II

FDA 510(k)

FDA Class 2 ·Cardiovascular

Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Fluorescence Mode

FDA 510(k)

FDA Class 2 ·Dental

PRIMUS

FDA 510(k)

FDA Class 2 ·Ophthalmic

Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDSTREAM TEST AND DIP/CARD STRIP

FDA 510(k)

FDA Class 2 ·Clinical Chemistry