RA 80 EIKEN KIT DETERM. OF RHEUMATIC F.

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 Kit Determ. Of Rheumatic F..

Pre-market Notification Details

Device IDK802448
510k NumberK802448
Device Name:RA 80 EIKEN KIT DETERM. OF RHEUMATIC F.
ClassificationSystem, Test, Rheumatoid Factor
Applicant SYN-KIT, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDHR  
CFR Regulation Number866.5775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-10-08
Decision Date1981-01-05

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