Asimanager - at

Q: When was Asimanager - at cleared by the FDA?

Asimanager - at (K111356) received a 510(k) decision of Substantially Equivalent on November 9, 2011, 177 days after the submission was received.

Q: What is the product code of K111356?

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.

FDA 510(k) K111356 · Arlington Scientific, Inc.

Substantially Equivalent

510(k) numberK111356

Submission

Device name: Asimanager - at
Applicant: Arlington Scientific, Inc.
Springville, UT, US
Received: May 16, 2011
Decision date: November 9, 2011
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

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)	Device	Applicant	Decision
K944185	IsoscanJQT · Traditional	Isolab, Inc.	11/17/1994SE
K915332	Model 795 Fluorometer/DensitometerJQT · Traditional	Ciba Corning Diagnostics Corp.	02/18/1992SE
K885254	Target ReaderJQT · Traditional	V-Tech, Inc.	01/27/1989SE
K860645	Electrophoresis Data Center (Edc)JQT · Traditional	Helena Laboratories	12/17/1986SE
K862956	Icon ReaderJQT · Traditional	Hybritech, Inc.	08/19/1986SE
K853734	Apollo DensitometerJQT · Traditional	Astral Medical Systems	09/25/1985SE
K851154	Electrophoresis Apparatus, for Clinical Use 160,18JQT · Traditional	Astral Medical Systems	05/13/1985SE
K850617	Corning 780 Fluorometer/DensitometerJQT · Traditional	Corning Medical & Scientific	03/12/1985SE
K850260	Gleman ACD-2020 Automatic Computing DensitometerJQT · Traditional	Gelman Sciences, Inc.	02/27/1985SE
K842313	Elvi 146 SeroscanJQT · Traditional	Logos Scientific, Inc.	09/10/1984SE

Questions and answers

When was Asimanager - at cleared by the FDA?

Asimanager - at (K111356) received a 510(k) decision of Substantially Equivalent on November 9, 2011, 177 days after the submission was received.

What is the product code of K111356?

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.