Cleared Traditional

CORNING 760 FLUOROMETER/DENSITOMETER

K803240 · Transidyne General Corp. · Chemistry

Jan 1981

Decision

17d

Days

Class 1

Risk

About This 510(k) Submission

K803240 is an FDA 510(k) clearance for the CORNING 760 FLUOROMETER/DENSITOMETER, a Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica (Class I — General Controls, product code JQT), submitted by Transidyne General Corp. (Mchenry, US). The FDA issued a Cleared decision on January 9, 1981, 17 days after receiving the submission on December 23, 1980. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2400.

Submission Details

510(k) Number	K803240 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 23, 1980
Decision Date	January 09, 1981
Days to Decision	17 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—

Device Classification

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