SUMMIT MEDICAL PRODUCTS, INC. 220569 ambIT

First Aid Kit Wihout Drug (Content : Adhesive bandages in a variety of different sizes and shapes + Non-adherent sterile Gauze Pad + Cleansing wipe (with alcohol)) This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

The Test of Variables of Attention (T.O.V.A.) kit contains the hardware and software necessary to install and administer the T.O.V.A. continuous performance test. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.

HIGHTOP Pregnancy Rapid Test Cassette is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy.

Cannabinoid test is an in vitro diagnostic test for the qualitative analysis of cannabinoids for employment and insurance testing.This Reagent, the Marijuana(THC) Rapid Test Cassette detects 11-nor-Delta9-THC-9-COOH in urine at concentrations equal to or greater than 50 ng/ml. The Marijuana (THC) Test is a rapid qualitative competitive binding immunoassay for determination of Marijuana in urine.