Definition: This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html.This Type Of Convenience Kit, As Listed In The Guidance Above, Is
| Device Type ID | 2860 |
| Device Name | Bone Marrow Collection/transfusion Kit |
| Physical State | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html.This Type Of Convenience Kit, As Listed In The Guidance Above, Is |
| Technical Method | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html.This Type Of Convenience Kit, As Listed In The Guidance Above, Is |
| Target Area | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html.This Type Of Convenience Kit, As Listed In The Guidance Above, Is |
| Review Panel | General Hospital |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | Enforcement Discretion |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LWE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2860 |
| Device | Bone Marrow Collection/transfusion Kit |
| Product Code | LWE |
| FDA Device Classification | Class 2 Medical Device |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
FRESENIUS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
FRESENIUS KABI | ||
SUBSTANTIALLY EQUIVALENT | 2 | |