Cleared Traditional

MODULAR SCANNING DENSITOMETER SYS.

K780318 · Transidyne General Corp. · Chemistry

Apr 1978

Decision

47d

Days

Class 1

Risk

About This 510(k) Submission

K780318 is an FDA 510(k) clearance for the MODULAR SCANNING DENSITOMETER SYS., 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 April 12, 1978, 47 days after receiving the submission on February 24, 1978. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2400.

Submission Details

510(k) Number	K780318 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 24, 1978
Decision Date	April 12, 1978
Days to Decision	47 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