Electrophoresis Data Center (Edc)
FDA 510(k) K860645 · Helena Laboratories
510(k) numberK860645
Submission
- Device name
- Electrophoresis Data Center (Edc)
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- February 20, 1986
- Decision date
- December 17, 1986
- 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
Other 510(k)s with product code JQT
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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 |
| 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 Electrophoresis Data Center (Edc) cleared by the FDA?
Electrophoresis Data Center (Edc) (K860645) received a 510(k) decision of Substantially Equivalent on December 17, 1986, 300 days after the submission was received.
What is the product code of K860645?
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.