ACCESS HYBRITECH FREE PSA QC, MODEL 37219

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 Hybritech Free Psa Qc, Model 37219.

Pre-market Notification Details

Device IDK993210
510k NumberK993210
Device Name:ACCESS HYBRITECH FREE PSA QC, MODEL 37219
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska,  MN  55318 -1084
ContactMichel Gust
CorrespondentMichel Gust
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 Received1999-09-24
Decision Date2000-01-05
Summary:summary

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