Device Type ID | 2393 |
Device Name | Chamber, Environmental For The Storage Of Platelet Concentrate |
Regulation Description | Environmental Chamber For Storage Of Platelet Concentrate. |
Regulation Medical Specialty | Hematology |
Review Panel | Hematology |
Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 864.9575 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | KSH |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |