Corning 780 Fluorometer/Densitometer
FDA 510(k) K850617 · Corning Medical & Scientific
510(k) numberK850617
Submission
- Device name
- Corning 780 Fluorometer/Densitometer
- Applicant
- Corning Medical & Scientific
Medfield, MA, US - Received
- February 15, 1985
- Decision date
- March 12, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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|---|---|---|---|
| K111356 | Asimanager - atJQT · Traditional | Arlington Scientific, Inc. | 11/09/2011SE |
| 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 |
| 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 Corning 780 Fluorometer/Densitometer cleared by the FDA?
Corning 780 Fluorometer/Densitometer (K850617) received a 510(k) decision of Substantially Equivalent on March 12, 1985, 25 days after the submission was received.
What is the product code of K850617?
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.