Device Type ID | 360 |
Device Name | Alpha-naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes |
Regulation Description | Alkaline Phosphatase Or Isoenzymes 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 | 862.1050 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | CJO |
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 | 360 |
Device | Alpha-naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes |
Product Code | CJO |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Alkaline Phosphatase Or Isoenzymes Test System. |
CFR Regulation Number | 862.1050 [🔎] |
Device Problems | |
---|---|
Low Test Results | 3 |
Pump | 1 |
Probe | 1 |
Syringe | 1 |
Total Device Problems | 6 |