Cleared Traditional

ISOSCAN

K944185 · Isolab, Inc. · Chemistry

Nov 1994

Decision

83d

Days

Class 1

Risk

About This 510(k) Submission

K944185 is an FDA 510(k) clearance for the ISOSCAN, a Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica (Class I — General Controls, product code JQT), submitted by Isolab, Inc. (Akron, US). The FDA issued a Cleared decision on November 17, 1994, 83 days after receiving the submission on August 26, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2400.

Submission Details

510(k) Number	K944185 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 26, 1994
Decision Date	November 17, 1994
Days to Decision	83 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	JQT — Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica
Device Class	Class I — General Controls
CFR Regulation	21 CFR 862.2400