OC-Light S FIT

Reagent, Occult Blood

EIKEN CHEMICAL CO. LTD

The following data is part of a premarket notification filed by Eiken Chemical Co. Ltd with the FDA for Oc-light S Fit.

Pre-market Notification Details

Device IDK143325
510k NumberK143325
Device Name:OC-Light S FIT
ClassificationReagent, Occult Blood
Applicant EIKEN CHEMICAL CO. LTD 4-19-9 TAITO Taito-ku,  JP 110-8408
ContactYoshinori Ota
CorrespondentTakashi Enomoto
EIKEN CHEMICAL CO. LTD 4-19-9 TAITO Taito-ku,  JP 110-8408
Product CodeKHE  
CFR Regulation Number864.6550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-11-20
Decision Date2015-08-20
Summary:summary

NIH GUDID Devices

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