| Device Type ID | 611 |
| Device Name | System, Test, Urinary Methylmalonic Acid |
| Regulation Description | Methylmalonic Acid (nonquantitative) 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) Exempt |
| CFR Regulation Number | 862.1509 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LPT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |