LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM.

System, Test, Blood Glucose, Over The Counter

INFOPIA CO., LTD

The following data is part of a premarket notification filed by Infopia Co., Ltd with the FDA for Lipidpro Lipid Profile And Glucose Measuring System, Lipidpro Professional Lipid Profile And Glucose Measuring System..

Pre-market Notification Details

Device IDK130295
510k NumberK130295
Device Name:LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM.
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant INFOPIA CO., LTD 2341 W CRESCENT AVE #3 Anaheim,  CA  92801
ContactPriscilla Chung
CorrespondentPriscilla Chung
INFOPIA CO., LTD 2341 W CRESCENT AVE #3 Anaheim,  CA  92801
Product CodeNBW  
Subsequent Product CodeCGA
Subsequent Product CodeCHH
Subsequent Product CodeJGY
Subsequent Product CodeJJX
Subsequent Product CodeLBR
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-02-06
Decision Date2013-06-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00763924540105 K130295 000
10763924532107 K130295 000
08809115905406 K130295 000
08809115905413 K130295 000
08809115905444 K130295 000
00695684773014 K130295 000
00695684773106 K130295 000
00695684773120 K130295 000
00695684774103 K130295 000
00695684774127 K130295 000
00695684775124 K130295 000
00695684775506 K130295 000
10763924550507 K130295 000
00850006113064 K130295 000
00860394001225 K130295 000
00860394001256 K130295 000
08809115904119 K130295 000

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