TRIGLYZYME V EIKEN

Colorimetric Method, Triglycerides

SYN-KIT, INC.

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

Pre-market Notification Details

Device IDK821106
510k NumberK821106
Device Name:TRIGLYZYME V EIKEN
ClassificationColorimetric Method, Triglycerides
Applicant SYN-KIT, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeJGY  
CFR Regulation Number862.1705 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-04-20
Decision Date1982-05-05

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