BLF EIKEN KIT DETER. OF B-LIPOPR. FRAC.

Nephelometric Method, Lipoproteins

SYN-KIT, INC.

The following data is part of a premarket notification filed by Syn-kit, Inc. with the FDA for Blf Eiken Kit Deter. Of B-lipopr. Frac..

Pre-market Notification Details

Device IDK802451
510k NumberK802451
Device Name:BLF EIKEN KIT DETER. OF B-LIPOPR. FRAC.
ClassificationNephelometric Method, Lipoproteins
Applicant SYN-KIT, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJHQ  
CFR Regulation Number862.1475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-10-08
Decision Date1981-01-09

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