UROPAPER EIKEN GP

Method, Enzymatic, Glucose (urinary, Non-quantitative)

SYN-KIT, INC.

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

Pre-market Notification Details

Device IDK843753
510k NumberK843753
Device Name:UROPAPER EIKEN GP
ClassificationMethod, Enzymatic, Glucose (urinary, Non-quantitative)
Applicant SYN-KIT, INC. 9231 ETON AVE. Chatsworth,  CA  91311
ContactIwao Matsuoka
CorrespondentIwao Matsuoka
SYN-KIT, INC. 9231 ETON AVE. Chatsworth,  CA  91311
Product CodeJIL  
CFR Regulation Number862.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-09-25
Decision Date1984-12-18

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