Opiate Eia Assay
FDA 510(k) K915180 · Diagnostic Reagents, Inc.
510(k) numberK915180
Submission
- Device name
- Opiate Eia Assay
- Applicant
- Diagnostic Reagents, Inc.
Santa Clara, CA, US - Received
- November 15, 1991
- Decision date
- January 22, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K253082 | LZI Buprenorphine II Enzyme ImmunoassayDJG · Traditional | Lin-Zhi International, Inc. | 01/16/2026SE |
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| K251634 | LZI Fentanyl III Enzyme ImmunoassayDJG · Special | Lin-Zhi International, Inc. | 06/18/2025SE |
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| 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 |
|---|---|---|
| K983268 | Modification of Tricyclic Serum Tox Eia AssayLFH · Traditional | 11/18/1998SE |
| K983812 | Napa Eia AssayLAN · Traditional | 11/16/1998SE |
| K983323 | Digoxin ImmunoassayKXT · Traditional | 11/12/1998SE |
| K983280 | Vancomycin Eia AssayLEH · Traditional | 11/06/1998SE |
| K983159 | Drugs of Abuse Urine Calibrators and ControlsDKB · Traditional | 11/05/1998SE |
| K973102 | Lidocaine Eia AssayKLR · Traditional | 09/12/1997SE |
| K972835 | 50NG/ML Cocaine Metabolite CalibratorDLJ · Traditional | 08/28/1997SE |
| K972526 | Methadone Eia AssayDJR · Traditional | 08/04/1997SE |
| K964212 | Quinidine Enzyme ImmunoassayLBZ · Traditional | 12/18/1996SE |
| K963835 | Digoxin Enzyme ImmunoassayKXT · Traditional | 12/10/1996SE |
Questions and answers
When was Opiate Eia Assay cleared by the FDA?
Opiate Eia Assay (K915180) received a 510(k) decision of Substantially Equivalent on January 22, 1992, 68 days after the submission was received.
What is the product code of K915180?
The FDA product code is DJG – Enzyme Immunoassay, Opiates, a Class II (moderate risk) device regulated under 21 CFR 862.3650.