Instant-View Bup/Nbup Urine Test. Instant-Verdict Bup/Nbup Urine Test; Instant-Confirmatory Bup/Nbup Urine Test
FDA 510(k) K060527 · Alfa Scientific Designs, Inc.
510(k) numberK060527
Submission
- Device name
- Instant-View Bup/Nbup Urine Test. Instant-Verdict Bup/Nbup Urine Test; Instant-Confirmatory Bup/Nbup Urine Test
- Applicant
- Alfa Scientific Designs, Inc.
Powat, CA, US - Received
- February 28, 2006
- Decision date
- July 25, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 |
|---|---|---|
| K173303 | INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW…DKZ · Traditional | 02/23/2018SE |
| K173212 | Instant-view-PLUS immunochemical Fecal Occult Blood TestKHE · Traditional | 02/15/2018SE |
| K152122 | Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test…DKZ · Traditional | 06/24/2016SE |
| K131645 | Instant-View Multi-Drug of Abuse Urine Test (Cup, Panel Cassette)DKZ · Abbreviated | 10/07/2013SE |
| K100051 | Instant-View Milti-Drug of Abuse Urine Test (Panel, Cup), Instant-Verdict Multi-Drug of…DJG · Abbreviated | 07/06/2010SE |
| K070660 | Instant-View Fecal Occult Blood (Fob) Rapid TestKHE · Traditional | 06/21/2007SE |
| K063545 | Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine Test(Cassette…DJG · Abbreviated | 05/07/2007SE |
| K042227 | Instant-View Troponin I TestMMI · Traditional | 11/19/2004SE |
| K024360 | Instant-View H. Pylori One Step Rapid TestLYR · Traditional | 06/10/2003SE |
| K022693 | Instant-View Tca Urine TestMLK · Abbreviated | 12/09/2002SE |
Questions and answers
When was Instant-View Bup/Nbup Urine Test. Instant-Verdict Bup/Nbup Urine Test; Instant-Confirmatory Bup/Nbup Urine Test cleared by the FDA?
Instant-View Bup/Nbup Urine Test. Instant-Verdict Bup/Nbup Urine Test; Instant-Confirmatory Bup/Nbup Urine Test (K060527) received a 510(k) decision of Substantially Equivalent on July 25, 2006, 147 days after the submission was received.
What is the product code of K060527?
The FDA product code is DJG – Enzyme Immunoassay, Opiates, a Class II (moderate risk) device regulated under 21 CFR 862.3650.