Micro-Strip for Opiate Metabolites
FDA 510(k) K973761 · Microdiagnostics, Inc.
510(k) numberK973761
Submission
- Device name
- Micro-Strip for Opiate Metabolites
- Applicant
- Microdiagnostics, Inc.
Laguna Niguel, CA, US - Received
- October 2, 1997
- Decision date
- December 24, 1997
- 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 |
| 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 |
|---|---|---|
| K011952 | Drugs of Abuse Multi-Test StripDKZ · Traditional | 10/25/2001SE |
| K991516 | Micro-Strip for Marijuana MetabolitesLDJ · Traditional | 08/05/1999SE |
| K991505 | Micro-Strip for Phencyclidine MetabolitesLCM · Traditional | 08/05/1999SE |
| K981388 | Micro-Strip for Cocaine MetabolitesDIO · Traditional | 05/29/1998SE |
| K974611 | Micro-Strip for Amphetamine MetabolitesDKZ · Traditional | 03/20/1998SE |
| K932304 | Micro Eia for Amphetamine MetabolitesDKZ · Traditional | 12/07/1993SE |
| K923468 | Micro Eia for Opiate MetabolitesDJG · Traditional | 09/15/1992SE |
| K914533 | Micro Eia for Cocaine MetabolitesDIO · Traditional | 12/10/1991SE |
| K914490 | Micro Eia for Marijuana MetabolitesLDJ · Traditional | 11/29/1991SE |
Questions and answers
When was Micro-Strip for Opiate Metabolites cleared by the FDA?
Micro-Strip for Opiate Metabolites (K973761) received a 510(k) decision of Substantially Equivalent on December 24, 1997, 83 days after the submission was received.
What is the product code of K973761?
The FDA product code is DJG – Enzyme Immunoassay, Opiates, a Class II (moderate risk) device regulated under 21 CFR 862.3650.