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510(k) K021927

Device
PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM
Applicant
BIOMET, INC.
510(k) number
K021927
Product code
LXG  
Decision
Substantially Equivalent (SESE)
Decision date
2002-07-12
Date received
2002-06-12
Regulation
862.2050
Classification name
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Medical specialty
Clinical Chemistry
Review panel
Hematology
Device class
1
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
LONNIE WITHAM
Address
56 E Bell Dr. Warsaw IN US 46581 46581

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LXG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K943466MINI S.F.T. (URINE PRESERVATIVE)Cambridge Diagnostic Products, Inc.1995-05-24
K896802MAGNET PADWestmark, Sterile Packing Systems, Inc. (Sps)1989-12-27

Legacy Summary#

summary

FDA Review#

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