HITACHI 717 CHEMISTRY ANALYZER

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

BOEHRINGER MANNHEIM CORP.

The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Hitachi 717 Chemistry Analyzer.

Pre-market Notification Details

Device IDK872494
510k NumberK872494
Device Name:HITACHI 717 CHEMISTRY ANALYZER
ClassificationAnalyzer, Chemistry (photometric, Discrete), For Clinical Use
Applicant BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis,  IN  46250 -0457
ContactCheri Emmons
CorrespondentCheri Emmons
BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis,  IN  46250 -0457
Product CodeJJE  
CFR Regulation Number862.2160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-06-24
Decision Date1987-07-09

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.