POC-AS10 AUTO SAMPLER

Test, Urea (breath Or Blood)

OTSUKA PHARMACEUTICAL CO., LTD.

The following data is part of a premarket notification filed by Otsuka Pharmaceutical Co., Ltd. with the FDA for Poc-as10 Auto Sampler.

Pre-market Notification Details

Device IDK092817
510k NumberK092817
Device Name:POC-AS10 AUTO SAMPLER
ClassificationTest, Urea (breath Or Blood)
Applicant OTSUKA PHARMACEUTICAL CO., LTD. 49 PLAIN ST. North Attleboro,  MA  02760
ContactCynthia A Sinclair
CorrespondentCynthia A Sinclair
OTSUKA PHARMACEUTICAL CO., LTD. 49 PLAIN ST. North Attleboro,  MA  02760
Product CodeMSQ  
CFR Regulation Number866.3110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-09-14
Decision Date2010-03-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04987035388517 K092817 000

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