Target(Tm) Cannabinoids-R Test
FDA 510(k) K910893 · V-Tech, Inc.
510(k) numberK910893
Submission
- Device name
- Target(Tm) Cannabinoids-R Test
- Applicant
- V-Tech, Inc.
El Monte, CA, US - Received
- March 4, 1991
- Decision date
- April 3, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LDJ – Enzyme Immunoassay, Cannabinoids
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3870
- Specialty
- Clinical Toxicology
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More from Healgen Scientific,, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K914303 | Target(Tm)-HogJHI · Traditional | 10/11/1991SE |
| 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 |
| K890295 | Target(Tm) Ck-MbJHY · Traditional | 08/15/1989SE |
Questions and answers
When was Target(Tm) Cannabinoids-R Test cleared by the FDA?
Target(Tm) Cannabinoids-R Test (K910893) received a 510(k) decision of Substantially Equivalent on April 3, 1991, 30 days after the submission was received.
What is the product code of K910893?
The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.