Cleared Traditional

APOLLO DENSITOMETER

K853734 · Astral Medical Systems · Chemistry

Sep 1985

Decision

19d

Days

Class 1

Risk

About This 510(k) Submission

K853734 is an FDA 510(k) clearance for the APOLLO DENSITOMETER, a Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica (Class I — General Controls, product code JQT), submitted by Astral Medical Systems (Santa Ana, US). The FDA issued a Cleared decision on September 25, 1985, 19 days after receiving the submission on September 6, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2400.

Submission Details

510(k) Number	K853734 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 06, 1985
Decision Date	September 25, 1985
Days to Decision	19 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