Device Type ID | 2297 |
Device Name | Control, Platelet |
Regulation Description | Hematology Quality Control Mixture. |
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 | 864.8625 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | GJP |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Program |
Device Type ID | 2297 |
Device | Control, Platelet |
Product Code | GJP |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Hematology Quality Control Mixture. |
CFR Regulation Number | 864.8625 [🔎] |