CENTRIPREP 100

Electrode, Ion Selective (non-specified)

AMICON, INC.

The following data is part of a premarket notification filed by Amicon, Inc. with the FDA for Centriprep 100.

Pre-market Notification Details

Device IDK900280
510k NumberK900280
Device Name:CENTRIPREP 100
ClassificationElectrode, Ion Selective (non-specified)
Applicant AMICON, INC. 17 CHERRY HILL DR. Danvers,  MA  01923
ContactJames M Delaney
CorrespondentJames M Delaney
AMICON, INC. 17 CHERRY HILL DR. Danvers,  MA  01923
Product CodeJJP  
CFR Regulation Number862.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-01-18
Decision Date1990-02-16

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