Device Type ID | 2394 |
Device Name | Lectins And Protectins |
Regulation Description | Lectins And Protectins. |
Regulation Medical Specialty | Hematology |
Review Panel | Hematology |
Premarket Review | Center For Biologics Evaluation & Research (CBER) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 864.9550 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | KSI |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2394 |
Device | Lectins And Protectins |
Product Code | KSI |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Lectins And Protectins. |
CFR Regulation Number | 864.9550 [🔎] |