ACCESS AFP QC ON THE ACCESS IMMUNOASSAY ANALYZER, MODEL NUMBER 33219

Single (specified) Analyte Controls (assayed And Unassayed)

BECKMAN COULTER, INC.

The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Afp Qc On The Access Immunoassay Analyzer, Model Number 33219.

Pre-market Notification Details

Device IDK981864
510k NumberK981864
Device Name:ACCESS AFP QC ON THE ACCESS IMMUNOASSAY ANALYZER, MODEL NUMBER 33219
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska,  MN  55318 -1084
ContactEllen M Voss
CorrespondentEllen M Voss
BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska,  MN  55318 -1084
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-05-27
Decision Date1998-06-12
Summary:summary

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