KET-1 Blood Ketone Monitoring System

Nitroprusside, Ketones (urinary, Non-quant.)

Apex Biotechnology Corp.

The following data is part of a premarket notification filed by Apex Biotechnology Corp. with the FDA for Ket-1 Blood Ketone Monitoring System.

Pre-market Notification Details

Device IDK182593
510k NumberK182593
Device Name:KET-1 Blood Ketone Monitoring System
ClassificationNitroprusside, Ketones (urinary, Non-quant.)
Applicant Apex Biotechnology Corp. No. 7, Li-Hsin Road V, Hsinchu Science Park Hsinchu,  TW 30078
ContactLisa Liu
CorrespondentLisa Liu
Apex Biotechnology Corp. No. 7, Li-Hsin Road V, Hsinchu Science Park Hsinchu,  TW 30078
Product CodeJIN  
CFR Regulation Number862.1435 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-09-20
Decision Date2018-12-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860060002341 K182593 000
00860060002334 K182593 000
00860060002327 K182593 000
00860060002310 K182593 000

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