Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes

Device Code: 338

Product Code(s): CIO

Device Classification Information

Device Type ID338
Device NameThymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes
Regulation DescriptionAlkaline Phosphatase Or Isoenzymes Test System.
Regulation Medical SpecialtyClinical Chemistry
Review PanelClinical Chemistry
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number862.1050 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeCIO
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID338
DeviceThymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes
Product CodeCIO
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionAlkaline Phosphatase Or Isoenzymes Test System.
CFR Regulation Number862.1050 [🔎]
TPLC Last Update: 2019-04-02 19:33:02

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