Urine Opiates (Opi) Screen Flex Reagent Cartridge, Catalog No. DF 90A
FDA 510(k) K000464 · Dade Behring, Inc.
510(k) numberK000464
Submission
- Device name
- Urine Opiates (Opi) Screen Flex Reagent Cartridge, Catalog No. DF 90A
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- February 11, 2000
- Decision date
- April 14, 2000
- 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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| 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 |
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| 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 |
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Questions and answers
When was Urine Opiates (Opi) Screen Flex Reagent Cartridge, Catalog No. DF 90A cleared by the FDA?
Urine Opiates (Opi) Screen Flex Reagent Cartridge, Catalog No. DF 90A (K000464) received a 510(k) decision of Substantially Equivalent on April 14, 2000, 63 days after the submission was received.
What is the product code of K000464?
The FDA product code is DJG – Enzyme Immunoassay, Opiates, a Class II (moderate risk) device regulated under 21 CFR 862.3650.