Device Type ID | 6229 |
Device Name | Fluorescence Polarization Immunoassay, Diphenylhydantoin (total) |
Regulation Description | Diphenylhydantoin 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 | 862.3350 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | LGR |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |