AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST (DEVICE OR CASSETTE)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HCG ER METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC CLINICAL METHOD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Test, Immunoassay, Biosensor, Hcg

FDA classification

FDA Class 2 ·Test, Immunoassay, Biosensor, Hcg

Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Visual, Pregnancy Hcg, Prescription Use

FDA classification

FDA Class 2 ·Visual, Pregnancy Hcg, Prescription Use

Device, Neurovascular Embolization

FDA classification

FDA Class 2 ·Device, Neurovascular Embolization

Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Kit, Test, Pregnancy, Hcg, Over The Counter

FDA classification

FDA Class 2 ·Kit, Test, Pregnancy, Hcg, Over The Counter

OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY

FDA 510(k)

FDA Class 2 ·Cardiovascular

IQ PRODUCTS TRIPLE-COLOR FLOW CYTOMETRY REAGENTS, IQ PRODUCTS CD45-FITC/CD4-PE/CD3-CYQ, IQ PRODUCTS CD45-FITC/CD8-PE/CDQ

FDA 510(k)

FDA Class 2 ·Hematology

HFT750U

FDA 510(k)

FDA Class 2 ·Anesthesiology

ULTRA-COVER PU-TRANSDUCER COVER

FDA 510(k)

FDA Class 2 ·Radiology

ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250

FDA 510(k)

FDA Class 2 ·Immunology

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·MFL5000 & DORNIER LITHOTRIPTERS (STATIOINARY & TRANSPORTABLE)

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·TRIPTER-X1 SERIES SHOCKWAVE LITHOTRIPTERS

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·ECONOLITH(TM) LITHOTRIPTER

AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·MEDSTONE STS-T LITHOTRIPTER

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER COMPACT S) AND DORNIER LITHOTRIPTER (STATIONARY & TRANSPORTABLE