Centrifuge, Blood Bank For In Vitro Diagnostic Use

Centrifuge, Blood-bank For In Vitro Diagnostic Use

Heraeus Inc.

The following data is part of a premarket notification filed by Heraeus Inc. with the FDA for Centrifuge, Blood Bank For In Vitro Diagnostic Use.

Pre-market Notification Details

Device IDBK900024
510k NumberBK900024
Device Name:Centrifuge, Blood Bank For In Vitro Diagnostic Use
ClassificationCentrifuge, Blood-bank For In Vitro Diagnostic Use
Applicant Heraeus Inc. 111a Corporate Blvd, S. Plainfield,  NJ  07080
Product CodeKSO  
CFR Regulation Number864.9275 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-07-15
Decision Date1992-11-05

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