Product code DNK
- Device name
- Thin Layer Chromatography, Morphine
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3640
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K151557 | EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - Methamphetamine | Nantong Egens Biotech Co., Ltd. | 2015-07-16 |
| K150602 | CR3 Keyless Split Sample Cup Morphine - Methamphetamine | Guangzhou Wondfo Biotech Co., Ltd. | 2015-04-07 |
| K970579 | ONE STEP MORPHINE CARD TEST | Teco Diagnostics | 1997-07-03 |
| K853140 | MDI QUIK TEST NARCOTICS DRUG SCREEN | Medical Diagnostics, Ca. | 1986-03-03 |
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| 16936983144671 | Discover | Hangzhou AllTest Biotech Co., Ltd. | 2023-11-30 |
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| 00643281710055 | First Check(R) | FIRST CHECK DIAGNOSTIC CORP. | 2018-04-11 |
| 10863451000428 | Quick Test | QUICKCO, LTD | 2018-02-22 |
| 00722066000830 | Rapid Response | BTNX Inc | 2016-10-25 |
| 00722066003541 | Rapid Response | BTNX Inc | 2016-10-25 |
| 10867802000273 | xCupTM | ESCREEN, INC. | 2016-09-24 |