DJCClass II
Thin Layer Chromatography, Methamphetamine
21 CFR 862.3610 / Clinical Toxicology
DJC is the FDA product code for Thin Layer Chromatography, Methamphetamine, a class II device type, regulated under 21 CFR 862.3610. As of , FDA records hold 31 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- DJC
- Device name
- Thin Layer Chromatography, Methamphetamine
- Regulation
- 21 CFR 862.3610
- Device class
- Class II
- Review panel
- Clinical Toxicology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 31
- Ingested recalls
- 0
Clearances, product code DJC
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1978 | 7 |
| 1999 | 1 |
| 2000 | 5 |
| 2001 | 2 |
| 2002 | 3 |
| 2003 | 2 |
| 2006 | 3 |
| 2008 | 1 |
| 2013 | 1 |
| 2016 | 1 |
| 2018 | 3 |
| 2025 | 1 |
| 2026 | 1 |
Applicants with the most clearances
Product code DJC| Applicant | Clearances |
|---|---|
| Alfa Scientific Designs, Inc. | 3 |
| ACRO BIOTECH Inc. | 2 |
| BD Becton Dickinson Vacutainer Systems Preanalytic | 2 |
| Branan Medical Corp. | 2 |
| Cordis US Corp. | 2 |
| MEDTOX Diagnostics, Inc. | 2 |
| Premier Biotech, LLC | 2 |
| Amedica Biotech, Inc. | 1 |
| American Bio Medica Corp. | 1 |
| Assure Tech. (Hangzhou) Co., Ltd. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
