Biometerplususa

FDA Filings

This page includes the latest FDA filings for Biometerplususa. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3010830834
FEI Number3004525092
NameBIOMETERPLUSUSA
Owner & Operatorbiometerplususa
Contact Address43102 christy st
Fremont CA 94538 US
Official Correspondent
  • paul shieh
  • 1-510-6204718-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address43102 christy st
Fremont, CA 94538 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
BIOMETERPLUSUSA
Uric acid test system, 862.1775,KNK.Class 12019-12-16
BIOMETERPLUSUSA
Triglyceride Test ( Lipase hydrolysis/glycerol kinase enzyme triglyceride),862.1705,Class 1, D3622772019-12-16
BIOMETERPLUSUSA
Ldl and Hdl Tests (Ldl & Vldl Preciptation, Cholesterol Via Esterase-oxidase, Hdl),862.1475,LBS,class 1, D3622762019-12-16
BIOMETERPLUSUSA
Glucose Test, 862.1345, CGA, Class 2, K050182, D2168882019-12-16
BIOMETERPLUSUSA
Creatinine test system, 862.1210, Class 12019-12-16
BIOMETERPLUSUSA
Cholesterol (total) Test (Enzymatic Esterase-oxidase, Cholesterol), 862.1175, CHH,Class 1, D2168882019-12-16
BIOMETERPLUSUSA
Q.Steps G/C Monitoring system2014-04-21
BIOMETERPLUSUSA
Q.Steps G/C Monitoring system2014-04-21
BIOMETERPLUSUSA
Q.Steps G/C Monitoring system2014-04-21
BIOMETERPLUSUSA
Q.Steps G/C Monitoring system2014-04-21

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