Electrophoresis Apparatus, for Clinical Use 160,18

FDA 510(k) K851154 · Astral Medical Systems

Substantially Equivalent

510(k) numberK851154

Submission

Device name
Electrophoresis Apparatus, for Clinical Use 160,18
Applicant
Astral Medical Systems
Buena Park, CA, US
Received
March 22, 1985
Decision date
May 13, 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
K853734Apollo DensitometerJQT · Traditional Astral Medical Systems09/25/1985SE
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
K853734Apollo DensitometerJQT · Traditional 09/25/1985SE

Questions and answers

When was Electrophoresis Apparatus, for Clinical Use 160,18 cleared by the FDA?

Electrophoresis Apparatus, for Clinical Use 160,18 (K851154) received a 510(k) decision of Substantially Equivalent on May 13, 1985, 52 days after the submission was received.

What is the product code of K851154?

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.