| Device Type ID | 2919 |
| Device Name | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control |
| Regulation Description | Antimitochondrial Antibody Immunological Test System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.5090 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DBM |
| 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 | 2919 |
| Device | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control |
| Product Code | DBM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Antimitochondrial Antibody Immunological Test System. |
| CFR Regulation Number | 866.5090 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
IMMCO DIAGNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INOVA DIAGNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PHADIA AB | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 1 |