QUANTA LITE ACA IGM (HRP)

FDA 510(k)

FDA Class 2 ·Immunology

Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK

FDA 510(k)

FDA Class 2 ·Cardiovascular

Wireless Smart Gluco-Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Tisuthes e-PTFE Surgical Patch

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TONOPORT VI

FDA 510(k)

FDA Class 2 ·Cardiovascular

BioHealx Anal Fistula Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

S8 EXP PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING

FDA 510(k)

FDA Class 2 ·Hematology

INVADER FACTOR II

FDA 510(k)

FDA Class 2 ·Hematology

cobas Factor II and Factor V Test

FDA 510(k)

FDA Class 2 ·Hematology

Xpert® FII & FV

FDA 510(k)

FDA Class 2 ·Hematology

FACTOR V LEIDEN KIT

FDA 510(k)

FDA Class 2 ·Hematology

INFINITI SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

INVADER FACTOR V

FDA 510(k)

FDA Class 2 ·Hematology

FACTOR II (PROTHROMBIN) G20210A KIT

FDA 510(k)

FDA Class 2 ·Hematology

ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II

FDA 510(k)

FDA Class 2 ·Hematology

XPERT HEMOSIL FACTOR II & FACTOR V ASSAY

FDA 510(k)

FDA Class 2 ·Hematology

Xpert® FII & FV

FDA 510(k)

FDA Class 2 ·Hematology

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·ACHILLES EXPRESS ULTRASONOMETER