Isoscan
FDA 510(k) K944185 · Isolab, Inc.
510(k) numberK944185
Submission
- Device name
- Isoscan
- Applicant
- Isolab, Inc.
Akron, OH, US - Received
- August 26, 1994
- Decision date
- November 17, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
More from Logos Scientific, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K951014 | Isolab's T4 Test KitKLI · Traditional | 10/18/1996SE |
| K950481 | Neonatal Chemistry System, Galactose Test KitJIA · Traditional | 02/01/1996SE |
| K943547 | Phenylalanine Test KitJNB · Traditional | 01/26/1996SE |
| K950803 | Isolab's GALACTOSE-1-PHOSPHATE Uridyl Tranferase Test Kits 800, 4000 SampleJJT · Traditional | 09/21/1995SE |
| K950415 | Fluoroscan NeonatalKHO · Traditional | 09/05/1995SE |
| K942276 | Quik-Sep Quantitative Hemoglobin S AssayGIQ · Traditional | 01/20/1995SE |
| K942222 | Quik-Sep Quantitive Hemoglobin S ControlsJCM · Traditional | 01/20/1995SE |
| K934013 | Resolve Systems Alkaline Phosphatase Test KitCIN · Traditional | 04/26/1994SE |
| K923153 | Hemocard, Hemoglobin C AssayMLL · Traditional | 01/27/1994SE |
| K931234 | Hemocard Control Hb-Aa, Ae, Faa, FaeJCM · Traditional | 05/11/1993SE |
Questions and answers
When was Isoscan cleared by the FDA?
Isoscan (K944185) received a 510(k) decision of Substantially Equivalent on November 17, 1994, 83 days after the submission was received.
What is the product code of K944185?
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.