SERIM RESIDUAL PEROXIDE/RENALIN TEST KIT

Dialyzer Reprocessing System

SERIM RESEARCH CORP.

The following data is part of a premarket notification filed by Serim Research Corp. with the FDA for Serim Residual Peroxide/renalin Test Kit.

Pre-market Notification Details

Device IDK900341
510k NumberK900341
Device Name:SERIM RESIDUAL PEROXIDE/RENALIN TEST KIT
ClassificationDialyzer Reprocessing System
Applicant SERIM RESEARCH CORP. P.O. BOX 4002 Elkhart,  IN  46514 -0002
ContactMichael Mckenna
CorrespondentMichael Mckenna
SERIM RESEARCH CORP. P.O. BOX 4002 Elkhart,  IN  46514 -0002
Product CodeLIF  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-01-22
Decision Date1990-07-11

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