UROPAPER EIKEG

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 Eikeg.

Pre-market Notification Details

Device IDK811815
510k NumberK811815
Device Name:UROPAPER EIKEG
ClassificationReagent, Occult Blood
Applicant SYN-KIT, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKHE  
CFR Regulation Number864.6550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-06-26
Decision Date1981-12-10

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