Phosphomolybdate (colorimetric), Inorganic Phosphorus

Device Code: 270

Product Code(s): CEO

Device Classification Information

Device Type ID270
Device NamePhosphomolybdate (colorimetric), Inorganic Phosphorus
Regulation DescriptionPhosphorus (inorganic) Test System.
Regulation Medical SpecialtyClinical Chemistry
Review PanelClinical Chemistry
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number862.1580 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeCEO
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID270
DevicePhosphomolybdate (colorimetric), Inorganic Phosphorus
Product CodeCEO
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionPhosphorus (inorganic) Test System.
CFR Regulation Number862.1580 [🔎]
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
TPLC Last Update: 2019-04-02 19:31:57

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.