iTind System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TISSUE OF ORIGIN TEST KIT FFPE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

everlinQ endoAVF System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Neuro Omega System, NeuroSmart System

FDA 510(k)

FDA Class 2 ·Neurology

Neuro Omega System; NeuroSmart System

FDA 510(k)

FDA Class 2 ·Neurology

OraQuick Ebola Rapid Antigen Test

FDA 510(k)

FDA Class 2 ·Microbiology

GAMMA PI BLOOD GROUP SUBSTANCE

FDA 510(k)

FDA Class 2 ·Hematology

NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

P1 BLOOD GROUP SUBSTANCE

FDA 510(k)

FDA Class 2 ·Hematology

Alinity m BKV

FDA 510(k)

FDA Class 2 ·Microbiology

LEWIS BLOOD GROUP SUBSTANCE

FDA 510(k)

FDA Class 2 ·Hematology

GAMMA LEWIS BLOOD GROUP SUBSTANCE

FDA 510(k)

FDA Class 2 ·Hematology

cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit

FDA 510(k)

FDA Class 2 ·Microbiology

Smith & Nephew Tablet Application

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BLOOD GROUP SUBSTANCE A

FDA 510(k)

FDA Class 2 ·Hematology

BLOOD GROUP SUBSTANCE A,B

FDA 510(k)

FDA Class 2 ·Hematology

BLOOD GROUP SUBSTANCE B

FDA 510(k)

FDA Class 2 ·Hematology

First To Know Syphilis Test

FDA 510(k)

FDA Class 2 ·Microbiology

Lenire Tinnitus Treatment Device

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

P1 BLOOD GROUP SUBSTANCE

FDA 510(k)

FDA Class 2 ·Hematology