BS-200 CHEMISTRY ANALYZER, MODE BS-200

Hexokinase, Glucose

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD

The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Bs-200 Chemistry Analyzer, Mode Bs-200.

Pre-market Notification Details

Device IDK072018
510k NumberK072018
Device Name:BS-200 CHEMISTRY ANALYZER, MODE BS-200
ClassificationHexokinase, Glucose
Applicant SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD 55 NORTHERN BLVD., SUITE 200 Great Neck,  NY  11021
ContactSusan D Goldstein-falk
CorrespondentSusan D Goldstein-falk
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD 55 NORTHERN BLVD., SUITE 200 Great Neck,  NY  11021
Product CodeCFR  
Subsequent Product CodeCEM
Subsequent Product CodeCGZ
Subsequent Product CodeJGS
Subsequent Product CodeJJE
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-07-23
Decision Date2008-02-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06944904084480 K072018 000
06944904018676 K072018 000

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