Apollo Densitometer

FDA 510(k) K853734 · Astral Medical Systems

Substantially Equivalent

510(k) numberK853734

Submission

Device name
Apollo Densitometer
Applicant
Astral Medical Systems
Santa Ana, CA, US
Received
September 6, 1985
Decision date
September 25, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JQT – Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
Device class
Class I (low risk)
Regulation
21 CFR 862.2400
Specialty
Clinical Chemistry

Other 510(k)s with product code JQT

510(k)DeviceApplicantDecision
K111356Asimanager - atJQT · Traditional Arlington Scientific, Inc.11/09/2011SE
K944185IsoscanJQT · Traditional Isolab, Inc.11/17/1994SE
K915332Model 795 Fluorometer/DensitometerJQT · Traditional Ciba Corning Diagnostics Corp.02/18/1992SE
K885254Target ReaderJQT · Traditional V-Tech, Inc.01/27/1989SE
K860645Electrophoresis Data Center (Edc)JQT · Traditional Helena Laboratories12/17/1986SE
K862956Icon ReaderJQT · Traditional Hybritech, Inc.08/19/1986SE
K851154Electrophoresis Apparatus, for Clinical Use 160,18JQT · Traditional Astral Medical Systems05/13/1985SE
K850617Corning 780 Fluorometer/DensitometerJQT · Traditional Corning Medical & Scientific03/12/1985SE
K850260Gleman ACD-2020 Automatic Computing DensitometerJQT · Traditional Gelman Sciences, Inc.02/27/1985SE
K842313Elvi 146 SeroscanJQT · Traditional Logos Scientific, Inc.09/10/1984SE

More from Logos Scientific, Inc.

510(k)DeviceDecision
K900506Modified Coatron II and Coatron Jr.JPA · Traditional 03/12/1990SE
K851153Coatron F(Same AS Coatron, But Also Does FibrinogeJPA · Traditional 11/05/1985SE
K851154Electrophoresis Apparatus, for Clinical Use 160,18JQT · Traditional 05/13/1985SE

Questions and answers

When was Apollo Densitometer cleared by the FDA?

Apollo Densitometer (K853734) received a 510(k) decision of Substantially Equivalent on September 25, 1985, 19 days after the submission was received.

What is the product code of K853734?

The FDA product code is JQT – Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica, a Class I (low risk) device regulated under 21 CFR 862.2400.