CENTRIFICHEM SYSTEM 500

Analyzer, Chemistry, Centrifugal, For Clinical Use

UNION CARBIDE CORP.

The following data is part of a premarket notification filed by Union Carbide Corp. with the FDA for Centrifichem System 500.

Pre-market Notification Details

Device IDK791180
510k NumberK791180
Device Name:CENTRIFICHEM SYSTEM 500
ClassificationAnalyzer, Chemistry, Centrifugal, For Clinical Use
Applicant UNION CARBIDE 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 Received1979-06-25
Decision Date1979-08-10

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