Device Type ID | 270 |
Device Name | Phosphomolybdate (colorimetric), Inorganic Phosphorus |
Regulation Description | Phosphorus (inorganic) 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 | 862.1580 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | CEO |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Program |
Device Type ID | 270 |
Device | Phosphomolybdate (colorimetric), Inorganic Phosphorus |
Product Code | CEO |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Phosphorus (inorganic) Test System. |
CFR Regulation Number | 862.1580 [🔎] |
Device Problems | |
---|---|
High Test Results | 8 |
Low Test Results | 5 |
Tube | 2 |
Probe | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Incorrect Measurement | 1 |
Washer | 1 |
Mechanical Problem | 1 |
Incorrect Or Inadequate Test Results | 1 |
Pump | 1 |
Device Subassembly | 1 |
Total Device Problems | 25 |