Blood Bank Centrifuges For In Vitro Diagnostic Use

Centrifuge, Blood-bank For In Vitro Diagnostic Use

E.I. DuPont De Nemours & Company

The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Company with the FDA for Blood Bank Centrifuges For In Vitro Diagnostic Use.

Pre-market Notification Details

Device IDBK910022
510k NumberBK910022
Device Name:Blood Bank Centrifuges For In Vitro Diagnostic Use
ClassificationCentrifuge, Blood-bank For In Vitro Diagnostic Use
Applicant E.I. DuPont De Nemours & Company medical Products Department Wilmington,  DE  19898
Product CodeKSO  
CFR Regulation Number864.9275 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-09-05
Decision Date1992-01-21

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