Target Amphetamine/Methamphetamine-R (Reader Meth)
FDA 510(k) K910739 · V-Tech, Inc.
510(k) numberK910739
Submission
- Device name
- Target Amphetamine/Methamphetamine-R (Reader Meth)
- Applicant
- V-Tech, Inc.
El Monte, CA, US - Received
- February 21, 1991
- Decision date
- March 21, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DKZ – Enzyme Immunoassay, Amphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3100
- Specialty
- Clinical Toxicology
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More from Alfa Scientific Designs, 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 |
| 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 |
| K890295 | Target(Tm) Ck-MbJHY · Traditional | 08/15/1989SE |
Questions and answers
When was Target Amphetamine/Methamphetamine-R (Reader Meth) cleared by the FDA?
Target Amphetamine/Methamphetamine-R (Reader Meth) (K910739) received a 510(k) decision of Substantially Equivalent on March 21, 1991, 28 days after the submission was received.
What is the product code of K910739?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.