DIG — Cholinesterase Test Paper Class I
FDA product code DIG covers "Cholinesterase Test Paper", a Class I medical device regulated under 21 CFR 862.3240. Submissions are reviewed by the Clinical Toxicology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- DIG
- Device Class
- Class I
- Regulation Number
- 862.3240
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K024339 | cozart bioscience | COZART EIA OPIATES ORAL FLUID KIT | April 7, 2003 |