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510(k) K103340

SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM by Harvest Technologies, Corp. — Product Code JQC

K103340 is an FDA 510(k) premarket notification submitted by Harvest Technologies, Corp. for the device "SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM". The FDA issued a decision of Substantially Equivalent on December 6, 2010. The device falls under product code JQC (Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use), a Class I device regulated under 21 CFR 862.2050. Harvest Technologies, Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2010
Date Received
November 15, 2010
Clearance Type
Special
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 by Harvest Technologies, Corp.

  • K121005 — ADIPREP ADIPOSE TRANSFER SYSTEM (September 21, 2012)
  • K052925 — SMARTPREP2 CENTRIFUGE SYSTEM (January 4, 2006)
  • K043261 — HARVEST GRAFT DELIVERY SYRINGE (March 11, 2005)
  • K020252 — SMARTJET GRAFTING LIQUID APPLICATOR, MODELS SK/S & LK/2 (April 5, 2002)
  • K011032 — SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE GRA (July 3, 2001)
  • K000456 — HARVEST TECHNOLOGIES DUAL LIQUID APPLICATOR, MODEL SK/S: HARVEST DUAL LIQUID AP (June 1, 2000)
  • K991430 — SMARTPREP CENTRIFUGE SYSTEM (May 28, 1999)
  • K983022 — SMARTCELL PROCESSING SYSTEM (April 2, 1999)

Other clearances for product code JQC

  • K183205 — PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiol (May 30, 2019)
  • 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)
  • K021902 — MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPA (August 12, 2002)

FDA data resources