Icon Reader
FDA 510(k) K862956 · Hybritech, Inc.
510(k) numberK862956
Submission
- Device name
- Icon Reader
- Applicant
- Hybritech, Inc.
San Diego, CA, US - Received
- August 5, 1986
- Decision date
- August 19, 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
More from Logos Scientific, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K972666 | Tandem-Mp Ostase Immunoenzymetric AssayCIN · Traditional | 09/11/1997SE |
| K961573 | Tandem-R Ostase Immunoradiometric AssayCIN · Traditional | 08/19/1996SE |
| K930810 | Tandem-R Ostase Immunoradiometric AssayCIN · Traditional | 01/11/1994SE |
| K922754 | Tandem-E Ige II Calibration Verification SetJJX · Traditional | 02/17/1993SE |
| K921745 | Hybritech Stratus Pap Fluorometric Enzyme ImmunoJFH · Traditional | 07/30/1992SE |
| K921252 | Tandem-E Ferritin Calibration Verification ConrolJJX · Traditional | 07/17/1992SE |
| K920556 | Tandem-E HCG Calibration Verification Control SetJJX · Traditional | 07/17/1992SE |
| K921763 | Tandem Icon QSR CKMB Immunoenzymetric AssayJHY · Traditional | 06/09/1992SE |
| K912439 | Tandem-E TSH Calibration Verification Control SetJJX · Traditional | 08/28/1991SE |
| K911417 | Icon Strep B Immunoenzymetric AssayGTZ · Traditional | 07/24/1991SE |
Questions and answers
When was Icon Reader cleared by the FDA?
Icon Reader (K862956) received a 510(k) decision of Substantially Equivalent on August 19, 1986, 14 days after the submission was received.
What is the product code of K862956?
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.