Device Type ID | 2249 |
Device Name | Protamine Sulphate |
Regulation Description | Heparin Assay. |
Regulation Medical Specialty | Hematology |
Review Panel | Hematology |
Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
Submission Type | 510(k) |
CFR Regulation Number | 864.7525 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | GFT |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
|
Device Type ID | 2249 |
Device | Protamine Sulphate |
Product Code | GFT |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Heparin Assay. |
CFR Regulation Number | 864.7525 [🔎] |