Device Type ID | 2395 |
Device Name | Solution, Stabilized Enzyme |
Regulation Description | Stabilized Enzyme Solution. |
Regulation Medical Specialty | Hematology |
Review Panel | Hematology |
Premarket Review | Center For Biologics Evaluation & Research (CBER) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 864.9400 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | KSK |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2395 |
Device | Solution, Stabilized Enzyme |
Product Code | KSK |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Stabilized Enzyme Solution. |
CFR Regulation Number | 864.9400 [🔎] |