Cleared Traditional

MODEL 795 FLUOROMETER/DENSITOMETER

K915332 · Ciba Corning Diagnostics Corp. · Chemistry

Feb 1992

Decision

84d

Days

Class 1

Risk

About This 510(k) Submission

K915332 is an FDA 510(k) clearance for the MODEL 795 FLUOROMETER/DENSITOMETER, a Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica (Class I — General Controls, product code JQT), submitted by Ciba Corning Diagnostics Corp. (East Walpole, US). The FDA issued a Cleared decision on February 18, 1992, 84 days after receiving the submission on November 26, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2400.

Submission Details

510(k) Number	K915332 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 26, 1991
Decision Date	February 18, 1992
Days to Decision	84 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement

Device Classification

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