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

ACR LAB Urine Analysis Test System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CARDIOTOMY RESERVOIR W/FILTER BCR-3500

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIOTOMY RESERVOIR W/FILTER#BCR-3500

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIOTOMY RESERVOIR W/FILTER BCR-2500

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

MRINNERVU DISPOSABLE ENDORECTAL CERVIX COIL#BCR-15

FDA 510(k)

FDA Class 2 ·Radiology

KODAK RADIATION ONCOLOGY SOFTWARE/ FOR ACR SYSTEMS

FDA 510(k)

FDA Class 2 ·Radiology

CARDIOTOMY RESERVORS BCR-3000/3500-Q-120

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

TROJAN-ENZ LATEX CONDOMS (MODIFIED LABELING)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

TROJAN FOR WOMEN LATEX CONDOMS W/SPERMI. MODIFIED

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

VIROGEN HSV ANTIBODY TEST

FDA 510(k)

FDA Class 2 ·Microbiology

DISCOVER(R)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TROJAN NATURALAMB LUBRICATED NATURAL MODIFIED

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology