Rapidone-Oxy Test
FDA 510(k) K014101 · American Bio Medica Corp.
510(k) numberK014101
Submission
- Device name
- Rapidone-Oxy Test
- Applicant
- American Bio Medica Corp.
Columbia, MD, US - Received
- December 13, 2001
- Decision date
- March 20, 2002
- 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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| 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 |
|---|---|---|
| K170222 | Rapid Tox Cup IILAF · Traditional | 08/15/2017SE |
| K073078 | Rapid Tox CupLAG · Traditional | 05/30/2008SE |
| K060760 | Rapidone-Buprenorphine TestDJG · Traditional | 08/07/2006SE |
| K053422 | RAPIDONE-COCAINE-150 TestDIO · Traditional | 06/15/2006SE |
| K053359 | RapidtoxDKZ · Special | 05/25/2006SE |
| K041696 | Rapid ReaderDKZ · Traditional | 07/12/2005SE |
| K041712 | 'Rapidtec 4' TestDIS · Traditional | 11/03/2004SE |
| K030835 | 'Rapid One' - Propoxyphene TestJXN · Traditional | 05/22/2003SE |
| K023869 | 'RAPIDTEC'-5M-MULTIPLE Dip TestDJR · Traditional | 04/30/2003SE |
| K021114 | 'Rapidtec' 5A Multiple Dip TestDKZ · Traditional | 07/23/2002SE |
Questions and answers
When was Rapidone-Oxy Test cleared by the FDA?
Rapidone-Oxy Test (K014101) received a 510(k) decision of Substantially Equivalent on March 20, 2002, 97 days after the submission was received.
What is the product code of K014101?
The FDA product code is DJG – Enzyme Immunoassay, Opiates, a Class II (moderate risk) device regulated under 21 CFR 862.3650.