RA 80 EIKEN

System, Test, Rheumatoid Factor

SYN-KIT, INC.

The following data is part of a premarket notification filed by Syn-kit, Inc. with the FDA for Ra 80 Eiken.

Pre-market Notification Details

Device IDK854820
510k NumberK854820
Device Name:RA 80 EIKEN
ClassificationSystem, Test, Rheumatoid Factor
Applicant SYN-KIT, INC. 9231 ETON AVE. Chatsworth,  CA  91311
ContactJames F Godfrey
CorrespondentJames F Godfrey
SYN-KIT, INC. 9231 ETON AVE. Chatsworth,  CA  91311
Product CodeDHR  
CFR Regulation Number866.5775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-12-03
Decision Date1986-01-17

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