UROPAPER EIKEN AG

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 Ag.

Pre-market Notification Details

Device IDK811817
510k NumberK811817
Device Name:UROPAPER EIKEN AG
ClassificationMethod, Enzymatic, Glucose (urinary, Non-quantitative)
Applicant SYN-KIT, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJIL  
CFR Regulation Number862.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-06-26
Decision Date1981-07-15

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