MSD CRP Assay Kit and MESO SECTOR S 700 Instrument

FDA 510(k)

FDA Class 2 ·Immunology

BIOFIRE FILMARRAY Tropical Fever Panel

FDA 510(k)

FDA Class 2 ·Microbiology

ULTRASOUND SCANNER, HUDSON MODELS 8000 AND 9000

FDA 510(k)

FDA Class 2 ·Radiology

FIRST CHECK MULTI DRUG CUP 12 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

HUDSON 2020, 2040, 2060,ULTRASOUND SCANNERS

FDA 510(k)

FDA Class 2 ·Radiology

BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)

FDA 510(k)

FDA Class 2 ·Pathology

ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PrimeStore MTM

FDA 510(k)

FDA Class 2 ·Microbiology

ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACE Hemoglobin A1c (HbA1c) Reagent

FDA 510(k)

FDA Class 2 ·Hematology

PADnet Xpress

FDA 510(k)

FDA Class 2 ·Cardiovascular

ORBIT

FDA 510(k)

FDA Class 2 ·Anesthesiology

Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack

FDA 510(k)

FDA Class 2 ·Microbiology

Aria

FDA 510(k)

FDA Class 2 ·Radiology

GEHC DXA Bone Densitometers with enCORE version 18

FDA 510(k)

FDA Class 2 ·Radiology

Vivid S60N, Vivid S70N

FDA 510(k)

FDA Class 2 ·Radiology

Voluson SWIFT; Voluson SWIFT+

FDA 510(k)

FDA Class 2 ·Radiology

LOGIQ V1/ LOGIQ V2

FDA 510(k)

FDA Class 2 ·Radiology

Vivid T8, Vivid T9

FDA 510(k)

FDA Class 2 ·Radiology