Target Opiates-R
FDA 510(k) K890978 · V-Tech, Inc.
510(k) numberK890978
Submission
- Device name
- Target Opiates-R
- Applicant
- V-Tech, Inc.
Pomona, CA, US - Received
- February 27, 1989
- Decision date
- November 17, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DJG – Enzyme Immunoassay, Opiates
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3650
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DJG
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|---|---|---|---|
| K252684 | Labcorp Fentanyl Urine Visual TestDJG · Traditional | Medtox Diagnostics, Inc. | 01/29/2026SE |
| K250741 | Evidence MultiSTAT DOA Urine MultiPlexDJG · Traditional | Randox Laboratories Limited | 01/23/2026SE |
| K253082 | LZI Buprenorphine II Enzyme ImmunoassayDJG · Traditional | Lin-Zhi International, Inc. | 01/16/2026SE |
| K252520 | SEFRIA Hydrocodone Oral FluidDJG · Traditional | Immunalysis Corporation | 09/11/2025SE |
| K251972 | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative…DJG · Traditional | Healgen Scientific,, LLC | 08/15/2025SE |
| K251634 | LZI Fentanyl III Enzyme ImmunoassayDJG · Special | Lin-Zhi International, Inc. | 06/18/2025SE |
| K240124 | BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA ReaderDJG · Traditional | Vivachek Biotech (Hangzhou) Co., Ltd. | 06/14/2024SE |
| K240698 | Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test DipcardDJG · Traditional | Guangzhou Decheng Biotechnology Co., Ltd. | 05/10/2024SE |
| K231904 | Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test DipcardDJG · Traditional | Co-Innovation Biotech Co., Ltd. | 03/08/2024SE |
| K232228 | Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine…DJG · Traditional | Shanghai Accurature Diagnostics Co., Ltd. | 02/23/2024SE |
More from Shanghai Accurature Diagnostics Co., Ltd.
| 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 |
| K890979 | Target Opiates-VDJG · Traditional | 10/04/1989SE |
| K890295 | Target(Tm) Ck-MbJHY · Traditional | 08/15/1989SE |
Questions and answers
When was Target Opiates-R cleared by the FDA?
Target Opiates-R (K890978) received a 510(k) decision of Substantially Equivalent on November 17, 1989, 263 days after the submission was received.
What is the product code of K890978?
The FDA product code is DJG – Enzyme Immunoassay, Opiates, a Class II (moderate risk) device regulated under 21 CFR 862.3650.