REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

TruDi Curette

FDA 510(k)

FDA Class 2 ·Neurology

T3 RIA (PEG) DIAGNOSTIC KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LABELING CHANGE CANNABINOIDS DOUBLE ANTI. IN URINE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

UCP HOME DRUG SCREENING TEST CUPS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MICROLINE SCREEN FOR METHAMPHETAMINE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST; INSTANT-CONFIRMATORY BUP/NBUP URINE TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

VANCOMYCIN FPIA REAGENT SET

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CEFOTAXIME 30 MCG. SENSI-DISC.

FDA 510(k)

FDA Class 2 ·Microbiology

Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MACHIDA NASOPHARYNGO-LARYNGOSCOPE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ANTIASTHMATIC CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ABUSCREEN(R) ONLINE(TM) FOR BENZODIAZEPINES

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MODIFICATION TO SCOOPER DRUG/ADULTERATION TEST CUP

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

TRACOR RA 410 AUDIOMETER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

EMIT CALIBRATOR LEVEL 1(CUTOFF)/LEVEL 2(HIGH)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MONTG. LARYNGEAL KEEL

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat