AFINION ACR AND ACR CONTROL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PORTABLE NURSING UNIT TERMINAL

FDA 510(k)

FDA Class 2 ·Cardiovascular

BCR-30-min BI™ and RBIP-ST30™ Readout Accessory

FDA 510(k)

FDA Class 2 ·General Hospital

CONTROL SERUMS FOR NONTREPONEMAL TEST

FDA 510(k)

FDA Class 2 ·Microbiology

ACR Screw System

FDA 510(k)

FDA Class 2 ·Dental

ACR ENZYMATIC GLUCOSE OXIDASE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACR 2500 CARDIOTOMY RESERVOIR FILTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

AP-6CR CINERADIOGRAPHIC FILM PROCESSOR

FDA 510(k)

FDA Class 2 ·Radiology

ACR LAB Urine Analysis Test System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems

FDA 510(k)

FDA Class 2 ·Medical Genetics

Quantidex qPCR BCR-ABL IS Kit

FDA 510(k)

FDA Class 2 ·Medical Genetics

QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System

FDA 510(k)

FDA Class 2 ·Medical Genetics

BCR-ABL1 (p210) % IS Kit (Digital PCR Method)

FDA 510(k)

FDA Class 2 ·Medical Genetics

MRDx BCR-ABL Test, MRDx BCR-ABL Test Software

FDA 510(k)

FDA Class 2 ·Medical Genetics

KODAK RADIATION ONCOLOGY SOFTWARE/ FOR ACR SYSTEMS

FDA 510(k)

FDA Class 2 ·Radiology

A O FIBER OPTIC ILLUMINATOR, 1185B

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

A O FIBER OPTIC ILLUMINATION, 1185A

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EFFNER FIBER OPTIC CABLES FOR COLD LIGHT TRANSMISS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TROJAN FOR WOMEN LUBRI. CONDOMS MODIFIED LABELING

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PREGNASLIDE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry