Home / 510(k) Clearances / K030340

510(k) K030340

AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129) by Cytomedix — Product Code JQC

K030340 is an FDA 510(k) premarket notification submitted by Cytomedix for the device "AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129)". The FDA issued a decision of Substantially Equivalent on April 11, 2003. The device falls under product code JQC (Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use), a Class I device regulated under 21 CFR 862.2050.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2003
Date Received
January 31, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Device Class
Class I
Regulation Number
862.2050
Review Panel
CH
Submission Type

Other clearances for product code JQC

  • K183205 — PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiol (May 30, 2019)
  • K103340 — SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM (December 6, 2010)
  • K081345 — AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY) (July 10, 2008)
  • K071934 — MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT (October 11, 2007)
  • K070666 — GENESISCS COMPONENT CONCENTRATING SYSTEM (June 20, 2007)
  • K052925 — SMARTPREP2 CENTRIFUGE SYSTEM (January 4, 2006)
  • K042473 — COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM (November 19, 2004)
  • K024080 — SECQUIRE CELL SEPARATOR (July 2, 2003)
  • K030555 — GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A (April 11, 2003)
  • K021902 — MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPA (August 12, 2002)

FDA data resources