UROPAPER EIKEN 8

Reagent, Occult Blood

SYN-KIT, INC.

The following data is part of a premarket notification filed by Syn-kit, Inc. with the FDA for Uropaper Eiken 8.

Pre-market Notification Details

Device IDK843532
510k NumberK843532
Device Name:UROPAPER EIKEN 8
ClassificationReagent, Occult Blood
Applicant SYN-KIT, INC. 9231 ETON AVE. Chatsworth,  CA  91311
ContactIwao Matsuoka
CorrespondentIwao Matsuoka
SYN-KIT, INC. 9231 ETON AVE. Chatsworth,  CA  91311
Product CodeKHE  
CFR Regulation Number864.6550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-09-07
Decision Date1984-12-12

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