AFINION ACR AND ACR CONTROL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACCENT AND EXCEED SERIES ORTHODONTIC CERAMIC BRACKETS

FDA 510(k)

FDA Class 2 ·Dental

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

CONVERTORS OPTI-SORB DRAPE MATERIAL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

WAMPOLE HS-CRP ELISA

FDA 510(k)

FDA Class 2 ·Immunology

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

TROJAN FOR WOMEN LUBRI. CONDOMS MODIFIED LABELING

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PREGNASLIDE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TROJAN (TM-TBD) CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology