NEG COMBO PANELS, NEG/URI MIC,NEG ID,POS MIC

FDA 510(k)

NEG COMBO BREAKPOINT PANEL POS COMBO

FDA 510(k)

FDA Class 1 ·Microbiology

ERICKA NEG. PRESSURE ARTERIAL BLOOD LINE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BLOOD LINE COMP. NEG. PRESS. PILLOW

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

QUIDEL QUICKVUE H. PYLORI CONTROLS (POS. AND NEG)

FDA 510(k)

FDA Class 1 ·Microbiology

VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO

FDA 510(k)

FDA Class 2 ·Microbiology

ADDIT. DATA FOR BREAKPOINT/ID GRAM-NEG. PANEL

FDA 510(k)

FDA Class 2 ·Microbiology

SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control

FDA 510(k)

FDA Class 2 ·Microbiology

SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)

FDA 510(k)

FDA Class 2 ·Microbiology

SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control

FDA 510(k)

FDA Class 2 ·Microbiology

Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL

FDA 510(k)

FDA Class 2 ·Microbiology

Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml

FDA 510(k)

FDA Class 2 ·Microbiology

STREP A NEGATIVE CONTROL

FDA 510(k)

FDA Class 1 ·Microbiology

Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CATHETERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

autoSCORE

FDA 510(k)

FDA Class 2 ·Neurology

EEGER4 MODEL 4.3

FDA 510(k)

FDA Class 2 ·Neurology

autoSCORE (V 2.0.0)

FDA 510(k)

FDA Class 2 ·Neurology

MS-39

FDA 510(k)

FDA Class 2 ·Ophthalmic