System, Test, Oxalate

Device Code: 612

Product Code(s): LPW

Device Classification Information

Device Type ID612
Device NameSystem, Test, Oxalate
Regulation DescriptionOxalate 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 Number862.1542 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeLPW
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID612
DeviceSystem, Test, Oxalate
Product CodeLPW
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionOxalate Test System.
CFR Regulation Number862.1542 [🔎]
TPLC Last Update: 2019-04-02 19:37:23

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