Cleared Traditional

DIAMATIC, AUTOMATIC INSULIN INJECTOR

K860284 · Ulster Scientific, Inc. · General Hospital
Apr 1986
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K860284 is an FDA 510(k) clearance for the DIAMATIC, AUTOMATIC INSULIN INJECTOR, a Introducer, Syringe Needle (Class II — Special Controls, product code KZH), submitted by Ulster Scientific, Inc. (Highland, US). The FDA issued a Cleared decision on April 7, 1986, 69 days after receiving the submission on January 28, 1986. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6920.

Submission Details

510(k) Number K860284 FDA.gov
FDA Decision Cleared SESE
Date Received January 28, 1986
Decision Date April 07, 1986
Days to Decision 69 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code KZH — Introducer, Syringe Needle
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6920