SUPREME II CONTROL SOLUTIONS

Single (specified) Analyte Controls (assayed And Unassayed)

CHRONIMED, INC.

The following data is part of a premarket notification filed by Chronimed, Inc. with the FDA for Supreme Ii Control Solutions.

Pre-market Notification Details

Device IDK983432
510k NumberK983432
Device Name:SUPREME II CONTROL SOLUTIONS
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant CHRONIMED, INC. 10900 RED CIRCLE DR. Minnetonka,  MN  55343
ContactJeffrey P Heaton
CorrespondentJeffrey P Heaton
CHRONIMED, INC. 10900 RED CIRCLE DR. Minnetonka,  MN  55343
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-09-29
Decision Date1998-12-17

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