Product Code: JQC FDA class 1 21 CFR 862.2050

Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use

Clinical Chemistry

The Centrifuges (Micro, Ultra, Refrigerated) for Clinical Use encompasses a range of laboratory centrifuge instruments used to separate blood, urine, or other biological specimens by centrifugal force for clinical laboratory analysis, including microcentrifuges, ultracentrifuges, and refrigerated models used for specialized separation protocols. This device is FDA Class 1, the lowest risk category, subject only to general controls with no premarket notification required. It carries product code JQC and is regulated under 21 CFR 862.2050, within the Clinical Chemistry medical specialty. This device is GMP exempt.

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510(k)s

FEI Numbers

163

Registration Numbers

163

Unique Applicants

Years Active

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Basic Information

Product Code: JQC
Device Class: FDA class 1
Regulation Number: 862.2050
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

Device Characteristics

✓

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 38 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K183205	PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System	May 30, 2019	Unknown	Emcyte Corporation
K103340	SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM	Dec 06, 2010	Substantially Equivalent	Harvest Technologies, Corp.
K081345	AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY)	Jul 10, 2008	Substantially Equivalent for Some Indications	Thermogenesis Corp.
K071934	MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT	Oct 11, 2007	Substantially Equivalent	Biomet Manufacturing Corp
K070666	GENESISCS COMPONENT CONCENTRATING SYSTEM	Jun 20, 2007	Substantially Equivalent	Perfusion Partners & Assoc., Inc.
K052925	SMARTPREP2 CENTRIFUGE SYSTEM	Jan 04, 2006	Substantially Equivalent	Harvest Technologies, Corp.
K042473	COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM	Nov 19, 2004	Substantially Equivalent	Cobe Cardiovascular, Inc.
K024080	SECQUIRE CELL SEPARATOR	Jul 02, 2003	Substantially Equivalent	Perfusion Partners & Assoc., Inc.
K030555	GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A	Apr 11, 2003	Substantially Equivalent	Biomet, Inc.
K030340	AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129)	Apr 11, 2003	Substantially Equivalent	Cytomedix
K021902	MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300	Aug 12, 2002	Substantially Equivalent	Medtronic Vascular
K994148	3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM	Feb 01, 2000	Substantially Equivalent	Implant Innovations, Inc.
K991430	SMARTPREP CENTRIFUGE SYSTEM	May 28, 1999	Substantially Equivalent	Harvest Technologies, LLC
K944738	SERIES 600 CENTRIFUGE-FOUR SEPARATE VARIATIONS OF THE SAME BASE CENTRIFUGE	Oct 19, 1994	Substantially Equivalent	Ducker CL
K881254	STATSPIN DISPOSABLE ROTOR, PRODUCT #RD01	Apr 05, 1988	Substantially Equivalent	Norfolk Scientific, Inc.
K864974	GENERAL PURPOSE CENTRIFUGE	Jan 09, 1987	Substantially Equivalent	Norfolk Scientific, Inc.
K861146	MODEL K110SX CENTRIFUGE	May 05, 1986	Substantially Equivalent	Jouan S.A.
K860747	DU PONT SORVALL CENTRIFUGES (RAPIDSPIN R)	Apr 14, 1986	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K860172	QWIKSPIN (TM)	Feb 11, 1986	Substantially Equivalent	Norfolk Scientific, Inc.
K850485	ROTOR SYSTEMS A/S-400 & LA/S-400	Mar 12, 1985	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K843434	ISO-DATA CENTRIFUGES 1-A, 101, 2D, ETC.	Oct 05, 1984	Substantially Equivalent	Iso-Data, Inc.
K843088	EBA 3 S CENTRIFUGE	Aug 29, 1984	Substantially Equivalent	Boehringer Mannheim Corp.
K843087	UNIVERSAL 2 S CENTRIFUGE	Aug 29, 1984	Substantially Equivalent	Boehringer Mannheim Corp.
K840768	CENTRIFUGES	May 07, 1984	Substantially Equivalent	Heraeus-Christ GmbH
K831948	LKB 2161 MIDISPIN R CENTRIFUGE	Jul 29, 1983	Substantially Equivalent	Lkb Instruments, Inc.
K831947	LKB 2160 MIDISPIN CENTRIFUGE	Jul 29, 1983	Substantially Equivalent	Lkb Instruments, Inc.
K831942	LKB 2164 MACRO-SPIN R CENTRIFUGE	Jul 29, 1983	Substantially Equivalent	Lkb Instruments, Inc.
K822715	PLATELET CENTRIFUGE	Sep 30, 1982	Substantially Equivalent	Biodynamics Corp.
K822422	BASIC CENTRIFUGE	Sep 02, 1982	Substantially Equivalent	Biodynamics Corp.
K821756	IEC CENTRA 4 CENTRIFUGE	Jun 25, 1982	Substantially Equivalent	International Equipment Co.
K813524	CENTIDISC	Dec 31, 1981	Substantially Equivalent	Bel-Art Products
K812505	PALL ULTIPOR VACUUM LINE BACTERIA FITLER	Sep 16, 1981	Substantially Equivalent	Pall Biomedical Products Co.
K810833	SORVALL RT6000 REFRIGERATED TABLETOP	Apr 08, 1981	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K802210	CONICAL TIPPED CENTRIFUGE TUBE 15M	Sep 26, 1980	Substantially Equivalent	Scientific Specialties, Inc.
K800381	REFRIG. CENTRIFUGE (DRUCKER MODEL)	Mar 19, 1980	Substantially Equivalent	Coulter Electronics, Inc.
K782124	IEC CENTRA-7 CENTRIFUGE MODEL 2362	Feb 26, 1979	Substantially Equivalent	Damon Corp.
K761013	SPINETTE CENTRIFUGE	Nov 16, 1976	Substantially Equivalent	Damon Corp.
K760467	ROTATOR, FIXED SPEED	Oct 29, 1976	Substantially Equivalent	Lederle Laboratories