CALIBRATING SOLUTION FOR ABL-1 & 2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Able Medical Devices Valkyrie Thoracic Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·MOBILE SENOGRAPHE 2000D

CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM)

FDA 510(k)

FDA Class 2 ·Microbiology

BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20)

FDA 510(k)

FDA Class 2 ·Microbiology

BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)

FDA 510(k)

FDA Class 2 ·Microbiology

ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS)

FDA 510(k)

FDA Class 2 ·Immunology

AUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/STOMACH)

FDA 510(k)

FDA Class 2 ·Immunology

MULTIPLE AUTO ANTIBODY TEST

FDA 510(k)

FDA Class 2 ·Immunology

AFT SYSTEM PROFICIENCY TESTING PROGRAM

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER

FDA 510(k)

FDA Class 2 ·Immunology

MEDICA IIF ANTI-SKIN ANTIBODY TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-SKIN ANTIBODY TEST(MONKEY/GUIN PIG ESOPH SEC)

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT

FDA 510(k)

FDA Class 2 ·Immunology

WIELISA ANTI-GBM TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-DS/N-DNA TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-RETICULIN ANTIBODY (ARA) TEST

FDA 510(k)

FDA Class 2 ·Immunology

RIT LIVER, KIDNEY, STOMACH IFA KIT

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-GBM ANTIBODIES QUANTITATIVE KIT

FDA 510(k)

FDA Class 2 ·Immunology