AMINO ACID ANALYSER SYSTEM

Analyzer, Chemistry, Micro, For Clinical Use

LKB INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Lkb Instruments, Inc. with the FDA for Amino Acid Analyser System.

Pre-market Notification Details

Device IDK803004
510k NumberK803004
Device Name:AMINO ACID ANALYSER SYSTEM
ClassificationAnalyzer, Chemistry, Micro, For Clinical Use
Applicant LKB INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJJF  
CFR Regulation Number862.2170 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-11-26
Decision Date1980-12-22

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