UROPAPER EIKEN GK

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 Gk.

Pre-market Notification Details

Device IDK843758
510k NumberK843758
Device Name:UROPAPER EIKEN GK
ClassificationMethod, Enzymatic, Glucose (urinary, Non-quantitative)
Applicant SYN-KIT, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
ContactIwao Matsuoka
CorrespondentIwao Matsuoka
SYN-KIT, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeJIL  
CFR Regulation Number862.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-09-25
Decision Date1984-12-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.