JQC · Class I · 21 CFR 862.2050

FDA Product Code JQC: Centrifuges (micro, Ultra, Refrigerated) For Clinical Use

Leading manufacturers include E.I. Dupont DE Nemours & Co., Inc., Lkb Instruments, Inc. and Norfolk Scientific, Inc..

38
Total
38
Cleared
48d
Avg days
1976
Since

FDA 510(k) Cleared Centrifuges (micro, Ultra, Refrigerated) For Clinical Use Devices (Product Code JQC)

38 devices
1–24 of 38
Cleared May 30, 2019
PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System
K183205
Emcyte Corporation
Hematology · 192d
Cleared Dec 06, 2010
SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM
K103340
Harvest Technologies, Corp.
Hematology · 21d
Cleared Jul 10, 2008
AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY)
K081345
Thermogenesis Corp.
Hematology · 57d
Cleared Oct 11, 2007
MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT
K071934
Biomet Manufacturing Corp
Hematology · 90d
Cleared Jun 20, 2007
GENESISCS COMPONENT CONCENTRATING SYSTEM
K070666
Perfusion Partners & Assoc., Inc.
Hematology · 100d
Cleared Jan 04, 2006
SMARTPREP2 CENTRIFUGE SYSTEM
K052925
Harvest Technologies, Corp.
Hematology · 78d
Cleared Nov 19, 2004
COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM
K042473
Cobe Cardiovascular, Inc.
Hematology · 67d
Cleared Jul 02, 2003
SECQUIRE CELL SEPARATOR
K024080
Perfusion Partners & Assoc., Inc.
Hematology · 204d
Cleared Apr 11, 2003
AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129)
K030340
Cytomedix
Hematology · 70d
Cleared Apr 11, 2003
GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A
K030555
Biomet, Inc.
Hematology · 49d
Cleared Aug 12, 2002
MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300
K021902
Medtronic Vascular
Hematology · 63d
Cleared Feb 01, 2000
3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM
K994148
Implant Innovations, Inc.
Immunology · 55d
Cleared May 28, 1999
SMARTPREP CENTRIFUGE SYSTEM
K991430
Harvest Technologies, LLC
Hematology · 32d
Cleared Oct 19, 1994
SERIES 600 CENTRIFUGE-FOUR SEPARATE VARIATIONS OF THE SAME BASE CENTRIFUGE
K944738
Ducker CL
Chemistry · 23d
Cleared Apr 05, 1988
STATSPIN DISPOSABLE ROTOR, PRODUCT #RD01
K881254
Norfolk Scientific, Inc.
Chemistry · 13d
Cleared Jan 09, 1987
GENERAL PURPOSE CENTRIFUGE
K864974
Norfolk Scientific, Inc.
Chemistry · 21d
Cleared May 05, 1986
MODEL K110SX CENTRIFUGE
K861146
Jouan S.A.
Chemistry · 40d
Cleared Apr 14, 1986
DU PONT SORVALL CENTRIFUGES (RAPIDSPIN R)
K860747
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 46d
Cleared Feb 11, 1986
QWIKSPIN (TM)
K860172
Norfolk Scientific, Inc.
Chemistry · 25d
Cleared Mar 12, 1985
ROTOR SYSTEMS A/S-400 & LA/S-400
K850485
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 33d
Cleared Oct 05, 1984
ISO-DATA CENTRIFUGES 1-A, 101, 2D, ETC.
K843434
Iso-Data, Inc.
Chemistry · 31d
Cleared Aug 29, 1984
UNIVERSAL 2 S CENTRIFUGE
K843087
Boehringer Mannheim Corp.
Chemistry · 23d
Cleared Aug 29, 1984
EBA 3 S CENTRIFUGE
K843088
Boehringer Mannheim Corp.
Chemistry · 23d
Cleared May 07, 1984
CENTRIFUGES
K840768
Heraeus-Christ GmbH
Hematology · 74d

About Product Code JQC - Regulatory Context