Target Reader
FDA 510(k) K885254 · V-Tech, Inc.
510(k) numberK885254
Submission
- Device name
- Target Reader
- Applicant
- V-Tech, Inc.
Pomona, CA, US - Received
- December 23, 1988
- Decision date
- January 27, 1989
- 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 |
| 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 |
|---|---|---|
| K914303 | Target(Tm)-HogJHI · Traditional | 10/11/1991SE |
| K910893 | Target(Tm) Cannabinoids-R TestLDJ · Traditional | 04/03/1991SE |
| K910892 | Target(Tm) Cannabinoids-V TestLDJ · Traditional | 04/03/1991SE |
| K910739 | Target Amphetamine/Methamphetamine-R (Reader Meth)DKZ · Traditional | 03/21/1991SE |
| K910738 | Target Amphetamine/Methamphetamine-V (Visual Meth)DKZ · Traditional | 03/19/1991SE |
| K910123 | Target Cocaine Metabolite-VKLN · Traditional | 03/19/1991SE |
| K910122 | Target Cocaine Metabolite-RKLN · Traditional | 03/19/1991SE |
| K903937 | Target(Tm) Hog One StepJHI · Traditional | 10/22/1990SE |
| K890978 | Target Opiates-RDJG · Traditional | 11/17/1989SE |
| K890979 | Target Opiates-VDJG · Traditional | 10/04/1989SE |
Questions and answers
When was Target Reader cleared by the FDA?
Target Reader (K885254) received a 510(k) decision of Substantially Equivalent on January 27, 1989, 35 days after the submission was received.
What is the product code of K885254?
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.