VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

STC COCAINE METABOLITE MICRO-PLATE EIA

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

URINE COCAINE METABOLITE (COC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

AT HOME DRUG TEST, MODEL 9073 T

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ACA DU PONT URINE COCAINE METABOLITE (U COC)SCREEN

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ONE STEP URINE DRUG OF ABUSE COCAINE TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

KOROT Blood Pressure Monitor (KOROT P3 Accurate)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)

FDA 510(k)

FDA Class 2 ·General Hospital

Plaxpot Multi Plasma

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BENCOX Mirabo Cup System

FDA 510(k)

FDA Class 2 ·Orthopedic

CANDIDA IMMUNODIFFUSION KIT #CA1001

FDA 510(k)

FDA Class 2 ·Microbiology

FUNGAL IMMUNODIFFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

CANDIDA IMMUNODIFFUSION KIT

FDA 510(k)

FDA Class 2 ·Microbiology

CANDIDA ALBICANS, ANTIGEN

FDA 510(k)

FDA Class 2 ·Microbiology

OLYMPUS PK-TP SYSTEM REACTIVE CONTROL

FDA 510(k)

FDA Class 2 ·Microbiology

COCCIDIOIDES IMMUNODIFFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology