ELECTROPHORESIS CONTROL LEVEL 1

Multi-analyte Controls, All Kinds (assayed)

SERADYN, INC.

The following data is part of a premarket notification filed by Seradyn, Inc. with the FDA for Electrophoresis Control Level 1.

Pre-market Notification Details

Device IDK925326
510k NumberK925326
Device Name:ELECTROPHORESIS CONTROL LEVEL 1
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant SERADYN, INC. P.O. BOX 1210 Indianapolis,  IN  46206
ContactAndris Indriksons
CorrespondentAndris Indriksons
SERADYN, INC. P.O. BOX 1210 Indianapolis,  IN  46206
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-10-21
Decision Date1993-03-26

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