Panels › Clinical Chemistry › Product code JQC · Class 1
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Regulation 862.2050
0510(k)s in 12 months (38 all time)
2recalls in 12 months (18 all time)
3recalls that name a 510(k)
Top companies in JQC
| Company | 510(k)s | Recalls |
|---|---|---|
| Beckman Coulter Inc | 0 | 4 |
| E.I. Dupont DE Nemours & Co., Inc. | 3 | 0 |
| Harvest Technologies, Corp. | 3 | 0 |
| Lkb Instruments, Inc. | 3 | 0 |
| LW Scientific, Inc. | 0 | 3 |
| Norfolk Scientific, Inc. | 3 | 0 |
| Biodynamics Corp. | 2 | 0 |
| Biomet, Inc. | 1 | 1 |
| Boehringer Mannheim Corp. | 2 | 0 |
| Cygnus LLC | 0 | 2 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 30, 2019 | K183205 | PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, Emcyte Corporation | JQC |
| Dec 6, 2010 | K103340 | SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM Harvest Technologies, Corp. | JQC |
| Jul 10, 2008 | K081345 | AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY) Thermogenesis Corp. | JQC |
| Oct 11, 2007 | K071934 | MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT Biomet Manufacturing Corp | JQC |
| Jun 20, 2007 | K070666 | GENESISCS COMPONENT CONCENTRATING SYSTEM Perfusion Partners & Assoc., Inc. | JQC |
| Jan 4, 2006 | K052925 | SMARTPREP2 CENTRIFUGE SYSTEM Harvest Technologies, Corp. | JQC |
| Nov 19, 2004 | K042473 | COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM Cobe Cardiovascular, Inc. | JQC |
| Jul 2, 2003 | K024080 | SECQUIRE CELL SEPARATOR Perfusion Partners & Assoc., Inc. | JQC |
| Apr 11, 2003 | K030555 | GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A Biomet, Inc. | JQC |
| Apr 11, 2003 | K030340 | AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129) Cytomedix | JQC |
| Aug 12, 2002 | K021902 | MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300 Medtronic Vascular | JQC |
| Feb 1, 2000 | K994148 | 3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM Implant Innovations, Inc. | JQC |
| May 28, 1999 | K991430 | SMARTPREP CENTRIFUGE SYSTEM Harvest Technologies, LLC | JQC |
| Oct 19, 1994 | K944738 | SERIES 600 CENTRIFUGE-FOUR SEPARATE VARIATIONS OF THE SAME BASE CENTRIFUGE Ducker CL | JQC |
| Apr 5, 1988 | K881254 | STATSPIN DISPOSABLE ROTOR, PRODUCT #RD01 Norfolk Scientific, Inc. | JQC |
| Jan 9, 1987 | K864974 | GENERAL PURPOSE CENTRIFUGE Norfolk Scientific, Inc. | JQC |
| May 5, 1986 | K861146 | MODEL K110SX CENTRIFUGE Jouan S.A. | JQC |
| Apr 14, 1986 | K860747 | DU PONT SORVALL CENTRIFUGES (RAPIDSPIN R) E.I. Dupont DE Nemours & Co., Inc. | JQC |
| Feb 11, 1986 | K860172 | QWIKSPIN (TM) Norfolk Scientific, Inc. | JQC |
| Mar 12, 1985 | K850485 | ROTOR SYSTEMS A/S-400 & LA/S-400 E.I. Dupont DE Nemours & Co., Inc. | JQC |
| Oct 5, 1984 | K843434 | ISO-DATA CENTRIFUGES 1-A, 101, 2D, ETC. Iso-Data, Inc. | JQC |
| Aug 29, 1984 | K843088 | EBA 3 S CENTRIFUGE Boehringer Mannheim Corp. | JQC |
| Aug 29, 1984 | K843087 | UNIVERSAL 2 S CENTRIFUGE Boehringer Mannheim Corp. | JQC |
| May 7, 1984 | K840768 | CENTRIFUGES Heraeus-Christ GmbH | JQC |
| Jul 29, 1983 | K831948 | LKB 2161 MIDISPIN R CENTRIFUGE Lkb Instruments, Inc. | JQC |
| Jul 29, 1983 | K831947 | LKB 2160 MIDISPIN CENTRIFUGE Lkb Instruments, Inc. | JQC |
| Jul 29, 1983 | K831942 | LKB 2164 MACRO-SPIN R CENTRIFUGE Lkb Instruments, Inc. | JQC |
| Sep 30, 1982 | K822715 | PLATELET CENTRIFUGE Biodynamics Corp. | JQC |
| Sep 2, 1982 | K822422 | BASIC CENTRIFUGE Biodynamics Corp. | JQC |
| Jun 25, 1982 | K821756 | IEC CENTRA 4 CENTRIFUGE International Equipment Co. | JQC |
| Dec 31, 1981 | K813524 | CENTIDISC Bel-Art Products | JQC |
| Sep 16, 1981 | K812505 | PALL ULTIPOR VACUUM LINE BACTERIA FITLER Pall Biomedical Products Co. | JQC |
| Apr 8, 1981 | K810833 | SORVALL RT6000 REFRIGERATED TABLETOP E.I. Dupont DE Nemours & Co., Inc. | JQC |
| Sep 26, 1980 | K802210 | CONICAL TIPPED CENTRIFUGE TUBE 15M Scientific Specialties, Inc. | JQC |
| Mar 19, 1980 | K800381 | REFRIG. CENTRIFUGE (DRUCKER MODEL) Coulter Electronics, Inc. | JQC |
| Feb 26, 1979 | K782124 | IEC CENTRA-7 CENTRIFUGE MODEL 2362 Damon Corp. | JQC |
| Nov 16, 1976 | K761013 | SPINETTE CENTRIFUGE Damon Corp. | JQC |
| Oct 29, 1976 | K760467 | ROTATOR, FIXED SPEED Lederle Laboratories | JQC |
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