Thin Layer Chromatography, Morphine
The Thin Layer Chromatography system for Morphine is a laboratory analytical device that uses thin-layer chromatographic separation to detect and identify morphine in patient biological specimens for toxicological screening or confirmation. It is a Class 2 device requiring a 510(k) premarket notification. The product code is DNK, regulated under 21 CFR 862.3640, within the Clinical Toxicology specialty. It is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- DNK
- Device Class
- FDA class 2
- Regulation Number
- 862.3640
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K151557 | EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - Methamphetamine | Jul 16, 2015 | Substantially Equivalent | Nantong Egens Biotech Co., Ltd. |
| K150602 | CR3 Keyless Split Sample Cup Morphine - Methamphetamine | Apr 07, 2015 | Substantially Equivalent | Guangzhou Wondfo Biotech Co., Ltd. |
| K970579 | ONE STEP MORPHINE CARD TEST | Jul 03, 1997 | Substantially Equivalent | Teco Diagnostics |
| K853140 | MDI QUIK TEST NARCOTICS DRUG SCREEN | Mar 03, 1986 | Substantially Equivalent | Medical Diagnostics, Ca. |
FEI Numbers
This FDA classification entry is associated with 21 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 21 registration numbers. Click on an entry to view related FDA registrations.