ENCORE CHEMISTRY ANALYZER

Analyzer, Chemistry, Centrifugal, For Clinical Use

BAKER INSTRUCTIONS CORP.

The following data is part of a premarket notification filed by Baker Instructions Corp. with the FDA for Encore Chemistry Analyzer.

Pre-market Notification Details

Device IDK832716
510k NumberK832716
Device Name:ENCORE CHEMISTRY ANALYZER
ClassificationAnalyzer, Chemistry, Centrifugal, For Clinical Use
Applicant BAKER INSTRUCTIONS CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJJG  
CFR Regulation Number862.2140 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-08-12
Decision Date1983-10-04

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