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 |