One Step Urine Drug of Abuse Opiate Test (Opium/Heroin/Morphine)
FDA 510(k) K952096 · Tcpi, Inc.
510(k) numberK952096
Submission
- Device name
- One Step Urine Drug of Abuse Opiate Test (Opium/Heroin/Morphine)
- Applicant
- Tcpi, Inc.
Pompano Beach, FL, US - Received
- May 4, 1995
- Decision date
- August 17, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DJG – Enzyme Immunoassay, Opiates
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3650
- Specialty
- Clinical Toxicology
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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 |
|---|---|---|
| K981363 | One Step Urine Drug of Abuse: Phencyclidine (PCP) TestLCM · Traditional | 12/22/1998SE |
| K972960 | Health Check Uri-Test Protein in UrineJIR · Traditional | 10/07/1998SE |
| K981197 | One Step Urine Drug of Abuse Amphetamine TestDKZ · Traditional | 06/16/1998SE |
| K980776 | One Step Urine Drug of Abuse: Benzodiazepine TestJXM · Traditional | 04/29/1998SE |
| K951853 | One Step Urine Drug of Abuse Cannabinoid Test (THC)LDJ · Traditional | 08/20/1996SE |
| K954968 | Health Check Uri-Test Glucose in Urine TestJIL · Traditional | 07/26/1996SE |
| K954685 | Uritest - Nitrite in Urine TestJMT · Traditional | 07/22/1996SE |
| K955353 | One Step Pregnancy HCG Serun Diluent ReagentJHI · Traditional | 03/19/1996SE |
| K951892 | One Step Urine Drug of Abuse Cocaine TestDIO · Traditional | 08/17/1995SE |
| K941765 | HCG Pregnancy One Step Test Strip for OTC UseLCX · Traditional | 10/20/1994SE |
Questions and answers
When was One Step Urine Drug of Abuse Opiate Test (Opium/Heroin/Morphine) cleared by the FDA?
One Step Urine Drug of Abuse Opiate Test (Opium/Heroin/Morphine) (K952096) received a 510(k) decision of Substantially Equivalent on August 17, 1995, 105 days after the submission was received.
What is the product code of K952096?
The FDA product code is DJG – Enzyme Immunoassay, Opiates, a Class II (moderate risk) device regulated under 21 CFR 862.3650.