ACCESS CHEMISTRY ANALYZER

Analyzer, Chemistry (photometric, Discrete), For Clinical Use

AMERICAN MONITOR CORP.

The following data is part of a premarket notification filed by American Monitor Corp. with the FDA for Access Chemistry Analyzer.

Pre-market Notification Details

Device IDK895423
510k NumberK895423
Device Name:ACCESS CHEMISTRY ANALYZER
ClassificationAnalyzer, Chemistry (photometric, Discrete), For Clinical Use
Applicant AMERICAN MONITOR CORP. P.O. BOX 68505 Indianapolis,  IN  46268
ContactJennifer Line
CorrespondentJennifer Line
AMERICAN MONITOR CORP. P.O. BOX 68505 Indianapolis,  IN  46268
Product CodeJJE  
CFR Regulation Number862.2160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-09-07
Decision Date1989-10-04

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