DIT — Thin Layer Chromatography, Amphetamine Class II
FDA product code DIT covers "Thin Layer Chromatography, Amphetamine", a Class II medical device regulated under 21 CFR 862.3100. Submissions are reviewed by the Clinical Toxicology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DIT
- Device Class
- Class II
- Regulation Number
- 862.3100
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K972577 | phamatech | QUICK SCREEN ONE STEP AMPHETAMINE TEST | August 20, 1997 |
| K910525 | drug screening systems | MICROLINE SCREEN FOR METHAMPHETAMINE | April 5, 1991 |
| K901276 | diagnostic products | HEMACON-DOA(TM) DRUGS OF ABUSE WHOLE BLOOD CONTROL | April 26, 1990 |
| K790805 | technical resources | DRUG ABUSE DIPSTICKS | June 6, 1979 |