P-toluenesulphonyl-l-arginine Methyl Ester (u.v.), Trypsin

Device Code: 536

Product Code(s): JNN

Device Classification Information

Device Type ID536
Device NameP-toluenesulphonyl-l-arginine Methyl Ester (u.v.), Trypsin
Regulation DescriptionTrypsin 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 Number862.1725 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeJNN
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID536
DeviceP-toluenesulphonyl-l-arginine Methyl Ester (u.v.), Trypsin
Product CodeJNN
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionTrypsin Test System.
CFR Regulation Number862.1725 [🔎]
TPLC Last Update: 2019-04-02 19:36:08

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