PLASMA CATECHOLAMINES BY HPLC

Chromatographic/fluorometric Method, Catecholamines

BIO-RAD

The following data is part of a premarket notification filed by Bio-rad with the FDA for Plasma Catecholamines By Hplc.

Pre-market Notification Details

Device IDK894966
510k NumberK894966
Device Name:PLASMA CATECHOLAMINES BY HPLC
ClassificationChromatographic/fluorometric Method, Catecholamines
Applicant BIO-RAD 4000 ALFRED NOBEL DR. Hercules,  CA  94547 -1803
ContactLynn C Shanta
CorrespondentLynn C Shanta
BIO-RAD 4000 ALFRED NOBEL DR. Hercules,  CA  94547 -1803
Product CodeCHQ  
CFR Regulation Number862.1165 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-08-07
Decision Date1989-10-25

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