Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use

FDA product code JQC · 38 cleared devices

Class 1 Clinical Chemistry

Regulation: 21 CFR 862.2050
Review panel: CH
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: Yes
Clearance span: 1976-10-29 – 2019-05-30

JQC 2019-05-30

PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System

Applicant Emcyte Corporation

K number K183205

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JQC 2010-12-06

SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM

Applicant Harvest Technologies, Corp.

K number K103340

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JQC 2008-07-10

AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY)

Applicant Thermogenesis Corp.

K number K081345

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JQC 2007-10-11

MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT

Applicant Biomet Manufacturing Corp

K number K071934

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JQC 2007-06-20

GENESISCS COMPONENT CONCENTRATING SYSTEM

Applicant Perfusion Partners & Assoc., Inc.

K number K070666

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JQC 2006-01-04

SMARTPREP2 CENTRIFUGE SYSTEM

Applicant Harvest Technologies, Corp.

K number K052925

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JQC 2004-11-19

COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM

Applicant Cobe Cardiovascular, Inc.

K number K042473

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JQC 2003-07-02

SECQUIRE CELL SEPARATOR

Applicant Perfusion Partners & Assoc., Inc.

K number K024080

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JQC 2003-04-11

GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A

Applicant Biomet, Inc.

K number K030555

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JQC 2003-04-11

AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129)

Applicant Cytomedix

K number K030340

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JQC 2002-08-12

MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300

Applicant Medtronic Vascular

K number K021902

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JQC 2000-02-01

3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM

Applicant Implant Innovations, Inc.

K number K994148

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JQC 1999-05-28

SMARTPREP CENTRIFUGE SYSTEM

Applicant Harvest Technologies, LLC

K number K991430

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JQC 1994-10-19

SERIES 600 CENTRIFUGE-FOUR SEPARATE VARIATIONS OF THE SAME BASE CENTRIFUGE

Applicant Ducker CL

K number K944738

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JQC 1988-04-05

STATSPIN DISPOSABLE ROTOR, PRODUCT #RD01

Applicant Norfolk Scientific, Inc.

K number K881254

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JQC 1987-01-09

GENERAL PURPOSE CENTRIFUGE

Applicant Norfolk Scientific, Inc.

K number K864974

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JQC 1986-05-05

MODEL K110SX CENTRIFUGE

Applicant Jouan S.A.

K number K861146

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JQC 1986-04-14

DU PONT SORVALL CENTRIFUGES (RAPIDSPIN R)

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K860747

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JQC 1986-02-11

QWIKSPIN (TM)

Applicant Norfolk Scientific, Inc.

K number K860172

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JQC 1985-03-12

ROTOR SYSTEMS A/S-400 & LA/S-400

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K850485

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JQC 1984-10-05

ISO-DATA CENTRIFUGES 1-A, 101, 2D, ETC.

Applicant Iso-Data, Inc.

K number K843434

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JQC 1984-08-29

EBA 3 S CENTRIFUGE

Applicant Boehringer Mannheim Corp.

K number K843088

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JQC 1984-08-29

UNIVERSAL 2 S CENTRIFUGE

Applicant Boehringer Mannheim Corp.

K number K843087

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JQC 1984-05-07

CENTRIFUGES

Applicant Heraeus-Christ GmbH

K number K840768

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JQC 1983-07-29

LKB 2161 MIDISPIN R CENTRIFUGE

Applicant Lkb Instruments, Inc.

K number K831948

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JQC 1983-07-29

LKB 2160 MIDISPIN CENTRIFUGE

Applicant Lkb Instruments, Inc.

K number K831947

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JQC 1983-07-29

LKB 2164 MACRO-SPIN R CENTRIFUGE

Applicant Lkb Instruments, Inc.

K number K831942

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JQC 1982-09-30

PLATELET CENTRIFUGE

Applicant Biodynamics Corp.

K number K822715

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JQC 1982-09-02

BASIC CENTRIFUGE

Applicant Biodynamics Corp.

K number K822422

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JQC 1982-06-25

IEC CENTRA 4 CENTRIFUGE

Applicant International Equipment Co.

K number K821756

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JQC 1981-12-31

CENTIDISC

Applicant Bel-Art Products

K number K813524

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JQC 1981-09-16

PALL ULTIPOR VACUUM LINE BACTERIA FITLER

Applicant Pall Biomedical Products Co.

K number K812505

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JQC 1981-04-08

SORVALL RT6000 REFRIGERATED TABLETOP

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K810833

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JQC 1980-09-26

CONICAL TIPPED CENTRIFUGE TUBE 15M

Applicant Scientific Specialties, Inc.

K number K802210

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JQC 1980-03-19

REFRIG. CENTRIFUGE (DRUCKER MODEL)

Applicant Coulter Electronics, Inc.

K number K800381

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JQC 1979-02-26

IEC CENTRA-7 CENTRIFUGE MODEL 2362

Applicant Damon Corp.

K number K782124

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JQC 1976-11-16

SPINETTE CENTRIFUGE

Applicant Damon Corp.

K number K761013

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JQC 1976-10-29

ROTATOR, FIXED SPEED

Applicant Lederle Laboratories

K number K760467

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