IMMUNODIFFUSION REAGENTS/SEROLOGICAL

FDA 510(k)

FDA Class 2 ·Microbiology

COCCIDIOIDES ANTIGEN #CF10023X

FDA 510(k)

FDA Class 2 ·Microbiology

CANDIDA ALBICANS, ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology

COCCIDIOIDES IMMITIS, ANTIGEN

FDA 510(k)

FDA Class 2 ·Microbiology

INFLUENZA B VIRUS CF ANTIGEN AND CONTROL ANTIGEN

FDA 510(k)

FDA Class 1 ·Microbiology

IMAGEN RESPIRATORY SCREEN

FDA 510(k)

FDA Class 1 ·Microbiology

DFA RESPIRATORY VIRUS SCREENING & ID KIT

FDA 510(k)

FDA Class 1 ·Microbiology

LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B

FDA 510(k)

FDA Class 1 ·Microbiology

D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT

FDA 510(k)

FDA Class 1 ·Microbiology

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G System

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·Artificial Pancreas Device System Threshold Suspend

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Paradigm Real-Time Reveal System

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 630G System With SmartGuard

Curaplex

FDA UDI

BOUND TREE MEDICAL, LLC·00810094575021·Curaplex THS VibraPEP, Filter, and Neb Kit

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G System

Sensor, Glucose, Invasive, Non-Adjunctive

FDA Pre-Market Approval

FDA Class 3 ·Simplera™ System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Paradigm Real-Time Revel System

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 530G System

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 630G System with SmartGuard