| Device Type ID | 6212 |
| Device Name | Enzyme Immunoassay, Valproic Acid |
| Regulation Description | Neuroleptic Drugs Radioreceptor Assay 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 | 862.3645 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LEG |
| 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 | 6212 |
| Device | Enzyme Immunoassay, Valproic Acid |
| Product Code | LEG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Neuroleptic Drugs Radioreceptor Assay Test System. |
| CFR Regulation Number | 862.3645 [🔎] |
| Device Problems | |
|---|---|
Low Test Results | 5 |
Mechanical Problem | 3 |
High Test Results | 2 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Appropriate Term/Code Not Available | 1 |
Insufficient Information | 1 |
| Total Device Problems | 13 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ortho-Clinical Diagnostics | II | Feb-19-2019 |