DOA - IMMUNOASSAY CUT-OFF CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Evidence MultiSTAT DOA Urine MultiPlex

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ACCUSIGN DOA 2, ACCUSIGN DOA, ACCUSIGN BAR/BZO, BIOSIGN DOA 2, BIOSIGN BAR/BZO, FIRST CHECK PANEL 2 BAR/BZO, STATUS DS B

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Breathe+

FDA 510(k)

FDA Class 2 ·Anesthesiology

ACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP,BIOSIGN DOA 10, BIOSIGN MET/OPI/COC/

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

COA-COMP/M, AUTOMATED BIPOLAR COAGULATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Keeogo Dermoskeleton System

FDA 510(k)

FDA Class 2 ·Physical Medicine

Chemtrue Multi-Panel DOA DIP Card Tests

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LIFESIGN DOA 4 (THC/OPI/COC/MET)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Fingertip pulse oximeter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60

FDA 510(k)

FDA Class 2 ·General Hospital

ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

uDR 780i

FDA 510(k)

FDA Class 2 ·Radiology

uMR 580, uMR 588

FDA 510(k)

FDA Class 2 ·Radiology

uDR 592h, uDR 596i

FDA 510(k)

FDA Class 2 ·Radiology

uCT ATLAS with uWS-CT-Dual Energy Analysis

FDA 510(k)

FDA Class 2 ·Radiology

Electronic Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular