Cleared Traditional

MICRO-MAT SYSTEM

K854962 · Ulster Scientific, Inc. · Hematology
Dec 1985
Decision
12d
Days
Class 1
Risk

About This 510(k) Submission

K854962 is an FDA 510(k) clearance for the MICRO-MAT SYSTEM, a Spinner, Slide, Automated (Class I — General Controls, product code GKJ), submitted by Ulster Scientific, Inc. (Highland, US). The FDA issued a Cleared decision on December 23, 1985, 12 days after receiving the submission on December 11, 1985. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5850.

Submission Details

510(k) Number K854962 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 1985
Decision Date December 23, 1985
Days to Decision 12 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GKJ — Spinner, Slide, Automated
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.5850