Device Type ID | 6161 |
Device Name | Amikacin Serum Assay |
Regulation Description | Amikacin Test System. |
Regulation Medical Specialty | Toxicology |
Review Panel | Toxicology |
Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
Submission Type | 510(k) |
CFR Regulation Number | 862.3035 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | KLP |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
Device Type ID | 6161 |
Device | Amikacin Serum Assay |
Product Code | KLP |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Amikacin Test System. |
CFR Regulation Number | 862.3035 [🔎] |