Home / 510(k) Clearances / K944738

510(k) K944738

SERIES 600 CENTRIFUGE-FOUR SEPARATE VARIATIONS OF THE SAME BASE CENTRIFUGE by Ducker CL — Product Code JQC

K944738 is an FDA 510(k) premarket notification submitted by Ducker CL for the device "SERIES 600 CENTRIFUGE-FOUR SEPARATE VARIATIONS OF THE SAME BASE CENTRIFUGE". The FDA issued a decision of Substantially Equivalent on October 19, 1994. 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
October 19, 1994
Date Received
September 26, 1994
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)
  • K030340 — AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129) (April 11, 2003)
  • K030555 — GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A (April 11, 2003)

FDA data resources