23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS)

FDA 510(k)

FDA Class 2 ·Immunology

Autosomal Recessive Carrier Screening Gene Mutation Detection System

FDA classification

FDA Class 2 ·Autosomal Recessive Carrier Screening Gene Mutation Detection System

DELFIA DIGOXIN

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CK-B RIA KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CARDIO CK-B RIA KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ANALYZER-SUPPLEMENT, KINETIC, LKB 2086

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LAPAROSCOPIC RETRACTORS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

STERILE WATER FOR INHALATION FLEX BAG, USP

FDA 510(k)

FDA Class 2 ·Anesthesiology

SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES)

FDA 510(k)

FDA Class 2 ·Neurology

INFLATABLE BONE TAMP

FDA 510(k)

FDA Class 2 ·Orthopedic

DIAGNOSTIC CATHETER SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AVAFLEX VERTEBRAL AUGMENTATION NEEDLE

FDA 510(k)

FDA Class 2 ·Orthopedic

COAXIAL BONE AND VERTEBRAL BODY BIOPSY NEEDLE MODEL# JBC1213, JBC1208

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PERIPHERAL NERVE STIMULATOR, MODEL A-200

FDA 510(k)

FDA Class 2 ·Anesthesiology

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·OMNISCEPT(TM) KB SYSTEM

BK-A; BK-B; BK-IS SEALING CAP

FDA 510(k)

FDA Class 2 ·Cardiovascular

CK-TOTAL/CK-B (NAC) BIOLUMIN. ASSAY KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DELFIA(TM) FERRITIN KIT

FDA 510(k)

FDA Class 2 ·Immunology

DELFIA(TM) HIGE KIT

FDA 510(k)

FDA Class 2 ·Immunology

DELFIA (TM) HTSH KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry