KDG Abutments

FDA 510(k)

FDA Class 2 ·Dental

KDG ACETABULAR COMPONENT

FDA 510(k)

FDA Class 2 ·Orthopedic

JJG EVOLUTION ORTHODONTIC IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

CYTOPREP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

epoc Blood Analysis System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EPOC BLOOD ANALYSIS SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EPOC CHLORIDE TEST AND EPOC CREATININE TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST; INSTANT-CONFIRMATORY BUP/NBUP URINE TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CEDIA Heroin Metabolite (6-AM) assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MICRO-STRIP FOR OPIATE METABOLITES

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

QUICKSCREEN PRO MULTI DRUG SCREEN, MODEL 9177 & 9178

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LZI Fentanyl II Enzyme Immunoassay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A

FDA 510(k)

FDA Class 2 ·Clinical Toxicology