RFA-300 RAPID FLOW ANALYZER W/COMPUTER

Analyzer, Chemistry, Micro, For Clinical Use

ALPKEM CORP.

The following data is part of a premarket notification filed by Alpkem Corp. with the FDA for Rfa-300 Rapid Flow Analyzer W/computer.

Pre-market Notification Details

Device IDK851542
510k NumberK851542
Device Name:RFA-300 RAPID FLOW ANALYZER W/COMPUTER
ClassificationAnalyzer, Chemistry, Micro, For Clinical Use
Applicant ALPKEM CORP. BOX 1260 Clackamas,  OR  97015
ContactOr Wi
CorrespondentOr Wi
ALPKEM CORP. BOX 1260 Clackamas,  OR  97015
Product CodeJJF  
CFR Regulation Number862.2170 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-04-16
Decision Date1985-05-10

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