Model 795 Fluorometer/Densitometer

Q: What is the product code of K915332?

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) K915332 · Ciba Corning Diagnostics Corp.

Substantially Equivalent

510(k) numberK915332

Submission

Device name: Model 795 Fluorometer/Densitometer
Applicant: Ciba Corning Diagnostics Corp.
East Walpole, MA, US
Received: November 26, 1991
Decision date: February 18, 1992
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement 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

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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

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Questions and answers

When was Model 795 Fluorometer/Densitometer cleared by the FDA?

Model 795 Fluorometer/Densitometer (K915332) received a 510(k) decision of Substantially Equivalent on February 18, 1992, 84 days after the submission was received.

What is the product code of K915332?

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.