← FDA Medical Device Classifications
Test System, Nicotine, Cotinine, Metabolites
MRS · Class I — Low Risk (general controls) · Clinical Toxicology · 21 CFR 862.3220
Classification
- FDA Product Code
MRS- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 862.3220
- Review panel
- TX
- Medical specialty
- Clinical Toxicology
- Submission type
- 4
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Market data
- Cleared 510(k) submissions
- 3
- Registered establishments
- 35
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown