HDL-C EIKEN

Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl

SYN-KIT, INC.

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

Pre-market Notification Details

Device IDK813192
510k NumberK813192
Device Name:HDL-C EIKEN
ClassificationLdl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
Applicant SYN-KIT, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeLBS  
CFR Regulation Number862.1475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-11-17
Decision Date1981-11-27

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