Device Type ID | 596 |
Device Name | Fluorescent Proc. (qual.), Galactose-1-phosphate Uridyl Transferase |
Regulation Description | Galactose-1-phosphate Uridyl Transferase Test System. |
Regulation Medical Specialty | Clinical Chemistry |
Review Panel | Clinical Chemistry |
Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
Submission Type | 510(k) |
CFR Regulation Number | 862.1315 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | KQP |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |