AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129)


Device Classification Name

centrifuges (micro, ultra, refrigerated) for clinical use

510(k) Number K030340
Device Name AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129)
Original Applicant
CYTOMEDIX
10952 steamboat loop, n.w.
walker, 
MN 
56484

Original Contact carelyn p fylling
Regulation Number 862.2050
Classification Product Code
JQC  
Date Received 01/31/2003
Decision Date 04/11/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Hematology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No