| Device Type ID | 301 |
| Device Name | Acid, Folic, Radioimmunoassay |
| Regulation Description | Folic Acid 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 | 862.1295 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | CGN |
| 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 | 301 |
| Device | Acid, Folic, Radioimmunoassay |
| Product Code | CGN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Folic Acid Test System. |
| CFR Regulation Number | 862.1295 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DIAZYME LABORATORIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIAGNOSTICS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIAGNOSTICS OPERATIONS, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SIEMENS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SIEMENS HEALTHCARE DIAGNOSTICS INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
High Test Results | 3 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Low Test Results | 2 |
Incorrect Or Inadequate Test Results | 1 |
Device Operates Differently Than Expected | 1 |
| Total Device Problems | 10 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ortho Clinical Diagnostics Inc | II | Oct-03-2018 |
| 2 | Siemens Healthcare Diagnostics, Inc | II | Sep-04-2015 |
| 3 | Siemens Healthcare Diagnostics, Inc | II | May-07-2014 |
| 4 | Siemens Healthcare Diagnostics, Inc. | II | May-04-2018 |
| 5 | Tosoh Bioscience Inc | II | Dec-22-2018 |