← FDA Medical Device Classifications
Atp And Creatine Kinase (Enzymatic), Creatine
JLB · Class I — Low Risk (general controls) · Clinical Chemistry · 21 CFR 862.1210
Classification
- FDA Product Code
JLB- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 862.1210
- Review panel
- CH
- Medical specialty
- Clinical Chemistry
- Submission type
- 4
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Market data
- Cleared 510(k) submissions
- 3
- Registered establishments
- 9
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown