Platelet Separation/Concentration System

Centrifuges (micro, Ultra, Refrigerated) For Clinical Use

Biomet Biologics, Inc.

The following data is part of a premarket notification filed by Biomet Biologics, Inc. with the FDA for Platelet Separation/concentration System.

Pre-market Notification Details

Device IDBK100027
510k NumberBK100027
Device Name:Platelet Separation/Concentration System
ClassificationCentrifuges (micro, Ultra, Refrigerated) For Clinical Use
Applicant Biomet Biologics, Inc. 56 East Bell Drive po Box 587 Warsaw,  IN  46581 US
Product CodeJQC  
CFR Regulation Number862.2050 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-04-02
Decision Date2010-05-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304681484 BK100027 000
00880304681477 BK100027 000
00880304640924 BK100027 000
00880304640917 BK100027 000

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