ELECTROPHORESIS CONTROL

Calibrator, Secondary

SERADYN, INC.

The following data is part of a premarket notification filed by Seradyn, Inc. with the FDA for Electrophoresis Control.

Pre-market Notification Details

Device IDK910160
510k NumberK910160
Device Name:ELECTROPHORESIS CONTROL
ClassificationCalibrator, Secondary
Applicant SERADYN, INC. P.O. BOX 1210 Indianapolis,  IN  46206
ContactMichael J Sullivan
CorrespondentMichael J Sullivan
SERADYN, INC. P.O. BOX 1210 Indianapolis,  IN  46206
Product CodeJIT  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-01-15
Decision Date1991-02-27

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