← FDA Medical Device Classifications
Spinner System, Cell Culture
KJE · Class I — Low Risk (general controls) · Hematology · 21 CFR 864.2240
Classification
- FDA Product Code
KJE- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 864.2240
- Review panel
- PA
- Medical specialty
- Hematology
- Submission type
- 4
- GMP exempt
- Y
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 6
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown