Research Use Only/hematology Devices
Device Code: 2502
Product Code(s):
OTQ Definition: For Research Use Only And For Products Imported Into The US Only.
Device Classification Information
Device Type ID | 2502 |
Device Name | Research Use Only/hematology Devices |
Physical State | N/A |
Technical Method | N/A |
Target Area | N/A |
Review Panel | Hematology |
Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
Submission Type | Enforcement Discretion |
FDA Device Classification | Class Not Classified Medical Device |
Product Code | OTQ |
GMP Exempt | Yes |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
Device Type ID | 2502 |
Device | Research Use Only/hematology Devices |
Product Code | OTQ |
TPLC Last Update: 2019-04-02 20:13:25