Product Code: JQW FDA class 1 21 CFR 862.2750

Station, Pipetting And Diluting, For Clinical Use

Clinical Chemistry

The Station, Pipetting and Diluting, For Clinical Use is a clinical laboratory instrument used to accurately dispense, pipette, and dilute liquid specimens and reagents in defined volumes for use in clinical chemistry assays and other diagnostic testing procedures, improving throughput and reducing manual pipetting errors. This device is FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. It carries product code JQW and is regulated under 21 CFR 862.2750, within the Clinical Chemistry medical specialty.

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510(k)s

140

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: JQW
Device Class: FDA class 1
Regulation Number: 862.2750
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 140 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K023955	BD VIPER INSTRUMENT	Jun 24, 2003	Substantially Equivalent	Becton, Dickinson & CO
K973335	QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE)	Apr 30, 1998	Substantially Equivalent	Zenyx Scientific , Ltd.
K980180	2700 SAMPLE MANAGER	Feb 12, 1998	Substantially Equivalent	Waters Corporation
K970420	MASTERCAP AM 5.0/MASTERCAP RM 5.0	Jun 30, 1997	Substantially Equivalent	Pharmacia, Inc.
K970616	MINI SAMPLER PROCESSOR	Apr 21, 1997	Substantially Equivalent	Cavro Scientific Instruments, Inc.
K962687	GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM	Mar 28, 1997	Substantially Equivalent	Nichols Institute Diagnostics
K962859	MINI SAMPLE PROCESSOR	Oct 29, 1996	Substantially Equivalent	Cavro Scientific Instruments, Inc.
K961896	MICROLAB 4000, MICROLAB 4200	Aug 16, 1996	Substantially Equivalent	Hamilton Co.
K961694	IMPACT	Jun 21, 1996	Substantially Equivalent	Matrix Technologies Corp.
K953345	GENESIS	Nov 21, 1995	Substantially Equivalent	Tecan U.S., Inc.
K951753	MEDTEC AUTOBLOT 2000	Oct 17, 1995	Substantially Equivalent	Medtec, Inc.
K952025	ROBOCAP	Jul 26, 1995	Substantially Equivalent	Pharmacia, Inc.
K944556	4 CHANNEL DISPENSER	Oct 25, 1994	Substantially Equivalent	Tecan U.S., Inc.
K942655	4 CHANNEL DISPENSER	Sep 02, 1994	Substantially Equivalent	Tecan U.S., Inc.
K942290	STAR I WORKSTATION	Aug 26, 1994	Substantially Equivalent	Standard Engineering
K941498	BIOMEK SL WITH BIOMEK SL INCUBATOR	Jul 14, 1994	Substantially Equivalent	Beckman Analytical and Biotechnology Development
K941394	STAT FAX 2600	Jun 03, 1994	Substantially Equivalent	Awareness Technology, Inc.
K940390	IMPACT	May 03, 1994	Substantially Equivalent	Matrix Technologies Corp.
K936258	SYSTEM WASHER 100	Apr 26, 1994	Substantially Equivalent	Eg&G Berthold
K934124	AUTOQUOT AUTOMATED ALIQUOTTING SYSTEM	Apr 13, 1994	Substantially Equivalent	Andronic Devices, Ltd.
K933088	PLATO 3000	Feb 25, 1994	Substantially Equivalent	Rosys, Inc.
K925547	MAXSOFTWARE	Jan 26, 1993	Substantially Equivalent	Diagnostic Products Corp.
K923879	ASSAY SOFTWARE FOR DPC-MARJ5 ALASTAT EIA SOFTWARE	Dec 07, 1992	Substantially Equivalent	Diagnostic Products Corp.
K922803	WELLWASH 4 MARK II	Nov 05, 1992	Substantially Equivalent	Denley Instruments, Inc.
K922327	DENLEY WELLPREP 2 SAMPLE PROCESSOR	Aug 12, 1992	Substantially Equivalent	Denley Instruments, Inc.
K922183	WELLPREP 2000 SAMPLE PROCESSOR	Aug 11, 1992	Substantially Equivalent	Denley Instruments, Inc.
K923268	AFFIRM PROCESSOR	Jul 30, 1992	Substantially Equivalent	Microprobe Corp.
K921005	AUTOLOADER	Apr 29, 1992	Substantially Equivalent	Innovative Medical Systems, Inc.
K915492	RSP MEGA SAMPLE PROCESSOR	Feb 21, 1992	Substantially Equivalent	Tecan U.S., Ltd.
K915284	STACKING MICROPLATE WASHER	Jan 22, 1992	Substantially Equivalent	Denley Instruments, Inc.
K913809	HY-PREP SYSTEM	Jan 15, 1992	Substantially Equivalent	Hyperion, Inc.
K913567	WELLPREP 1	Oct 04, 1991	Substantially Equivalent	Denley Instruments, Inc.
K913664	ROSYS MODELS 100 AND 200	Aug 30, 1991	Substantially Equivalent	Packard Instrument Co., Inc.
K912036	ROBOTIC SAMPLE PROCESSOR	Jul 26, 1991	Substantially Equivalent	Tecan U.S., Ltd.
K912228	MARK 5 ROBOTIC PIPETTOR	Jun 06, 1991	Substantially Equivalent	Diagnostic Products Corp.
K911712	STRATUS(R) AUTOMATED SAMPLE HANDLER	May 15, 1991	Substantially Equivalent	Baxter Healthcare Corp
K910140	ELECTRAPETTE (R)	Feb 04, 1991	Substantially Equivalent	Matrix Technologies Corp.
K902592	EPC ELECTRONIC PIPETTING SYSTEM	Jul 19, 1990	Substantially Equivalent	Ulster Scientific, Inc.
K900599	MICROPLATE REAGENT DISPENSER	May 17, 1990	Substantially Equivalent	Denley Instruments, Inc.
K896684	KEMBLE LIQUID HANDLING SYSTEM DISPENSER	Apr 16, 1990	Substantially Equivalent	Schiff & Co.
K896631	EXEC-WASH SOLID PHASE WASHING SYSTEM	Apr 03, 1990	Substantially Equivalent	Source Scientific Systems, Inc.
K900775	NOVAPATH SP ADVANCED LIQUID HANDLING SYSTEM	Mar 09, 1990	Substantially Equivalent	Bio-Rad
K897158	ABBOTT COMMANDER PARALLEL PROCESSING CENTER	Mar 01, 1990	Substantially Equivalent	Abbott Laboratories
K893811	SAKURA PREP AI AUTOMATIC LIQUID HANDLING SYSTEM	Sep 07, 1989	Substantially Equivalent	Sakura Finetek U.S.A., Inc.
K894710	DPC-ROBOSTAT(TM)	Aug 31, 1989	Substantially Equivalent	Diagnostic Products Corp.
K894272	DENLEY WELLDILL 3	Aug 21, 1989	Substantially Equivalent	Denley Instruments, Inc.
K894069	ABBOTT COMMANDER FLEXIBLE PIPETTING CENTER	Aug 21, 1989	Substantially Equivalent	Abbott Laboratories
K894271	DENLEY WELLWASH 2 AND 4	Aug 15, 1989	Substantially Equivalent	Denley Instruments, Inc.
K894126	ROBOTIC SAMPLE PROCESSOR	Aug 15, 1989	Substantially Equivalent	Tecan U.S., Ltd.
K893810	IMMUNO-WASH AUTOMATED TUBE WASHER	Aug 03, 1989	Substantially Equivalent	Ocean Scientific, Inc.
K893775	DU PONT DIMENSION PSID CLINICAL CHEMISTRY SYSTEM	Jul 25, 1989	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K893400	SERUMAX (AUTOMATED SERUM CENTRIFUGATION & STATION)	Jun 23, 1989	Substantially Equivalent	Medical Robotics
K893031	DELTA (TM) ROBOTIC PIPETTOR	Jun 21, 1989	Substantially Equivalent	Diagnostic Products Corp.
K890578	HI CHEM WASH CONCENTRATE REAGENT #88805	Mar 10, 1989	Substantially Equivalent	Hichem Diagnostics
K885340	AIR DISPLACEMENT PIPETTE	Feb 14, 1989	Substantially Equivalent	Ulster Scientific, Inc.
K883470	IDS-1600 SAMPLE HANDLING SYSTEM	Dec 09, 1988	Substantially Equivalent	Baxter Healthcare Corp
K883749	PROBE(TM) MODELS 700 AND 1000	Nov 10, 1988	Substantially Equivalent	Packard Instrument Co., Inc.
K881195	DYNATECH SPD 2000, NUMBER 002-910-0000	Jun 07, 1988	Substantially Equivalent	Dynatech Laboratories, Inc.
K873416	MULTI-ACCESS REAGENT DISPENSER	Oct 09, 1987	Substantially Equivalent	Electro-Nucleonics Laboratories, Inc.
K872363	DYNATECH SPD 3000, #002-900-0000	Jul 16, 1987	Substantially Equivalent	Dynatech Laboratories, Inc.
K871687	TYTEM(R) REAGENT DISPENSER	May 20, 1987	Substantially Equivalent	Medical Laboratory Automation Systems, Inc.
K870544	BIOMEK 1000 AUTOMATED LABORATORY WORK STATION	Apr 22, 1987	Substantially Equivalent	Beckman Instruments, Inc.
K870406	SMI DIGITRON	Feb 25, 1987	Substantially Equivalent	American Dade
K864875	ELECTRA AUTOMATIC SAMPLER	Feb 13, 1987	Substantially Equivalent	Medical Laboratory Automation Systems, Inc.
K863887	SMI MULTIPETTOR(TM)	Nov 05, 1986	Substantially Equivalent	American Dade
K863624	ULTRAWASH II	Oct 21, 1986	Substantially Equivalent	Dynatech Laboratories, Inc.
K863623	ULTRAWASH I	Oct 21, 1986	Substantially Equivalent	Dynatech Laboratories, Inc.
K862701	SURESPOT	Aug 19, 1986	Substantially Equivalent	Helena Laboratories
K861580	PROGROUP (TM) AUTOMATED LIQUID HANDLING SYSTEM	Jun 27, 1986	Substantially Equivalent	Cetus Corp.
K861640	MODUMATIC (R) DILUTER	May 23, 1986	Substantially Equivalent	Tri-Continent Scientific, Inc.
K860508	POSID SAMPLER	May 02, 1986	Substantially Equivalent	Organon Teknika Corp.
K854406	TECAN ROBOTIC SAMPLE PROCESSOR(RSP) #500	Feb 10, 1986	Substantially Equivalent	Tecan U.S., Ltd.
K852285	DADE BLOOD GAS AMPUL INJECTOR	Jul 09, 1985	Substantially Equivalent	American Dade
K851403	VENTREZYME ALLERGEN DATA REDUCTION SYSTEM	Jun 21, 1985	Substantially Equivalent	Ventrex Laboratories, Inc.
K850800	DROPSTIRS - PLASTIC DISPOSABLE PIPET	Apr 02, 1985	Substantially Equivalent	Berwick Medical Products, Inc.
K844798	EPPENDORF DILUTER	Jan 07, 1985	Substantially Equivalent	Medical Technomics, Ltd.
K843779	AUTOLOADER II	Jan 03, 1985	Substantially Equivalent	Electro-Nucleonics Laboratories, Inc.
K843621	FIAX 420 DILUTOR	Sep 28, 1984	Substantially Equivalent	Intl. Diagnostic Technology
K843607	LABOPETTOR	Sep 21, 1984	Substantially Equivalent	Medical Technomics, Ltd.
K843606	PRECISION DISPENSER	Sep 21, 1984	Substantially Equivalent	Medical Technomics, Ltd.
K842894	KEMBLE 405	Aug 27, 1984	Substantially Equivalent	Kemble Instruments, Inc.
K843073	FIXED VOL. DISPENSERS, ADJUST VOL-HUNPIP	Aug 24, 1984	Substantially Equivalent	Greene International Corp.
K842390	SYVA IQ 190 DIGITAL PIPETTER DILUTER	Jul 25, 1984	Substantially Equivalent	Syva Co.
K841043	BEHRING ELISA PROCESSOR M	Jul 06, 1984	Substantially Equivalent	Behring Diagnostics, Inc.
K840938	HIGH SPEED DISPENSER	Apr 19, 1984	Substantially Equivalent	Micromedic Systems
K834590	ACCUFLEX	Mar 19, 1984	Substantially Equivalent	Micromedic Systems
K833959	MICROLAB M DILUTER/DISPENSER	Jan 24, 1984	Substantially Equivalent	Syva Co.
K833666	UR/RITE SYSTEM	Jan 13, 1984	Substantially Equivalent	Wright Laboratories, Inc.
K833505	IL MODEL 840 MICROPROCESSOR LOADER	Jan 11, 1984	Substantially Equivalent	Instrumentation Laboratory CO
K832809	ACCU-PREP PROGRAMMABLE AUTO-DILUTER	Oct 27, 1983	Substantially Equivalent	Beckman Instruments, Inc.
K832205	PRECISION LIQUID DISPENSER	Aug 24, 1983	Substantially Equivalent	Hamilton Co.
K832204	MICROLAB P	Aug 24, 1983	Substantially Equivalent	Hamilton Co.
K832202	PB 600 REPEATING DISPENSER	Aug 24, 1983	Substantially Equivalent	Hamilton Co.
K831249	PRO QUANTUM	Jul 28, 1983	Substantially Equivalent	Abbott Laboratories
K831273	QST TM SAMPLE PROCESSOR	Jun 02, 1983	Substantially Equivalent	Syva Co.
K830319	AUTO PREP	Mar 29, 1983	Substantially Equivalent	Pm America, Inc.
K830157	DIGIFLEX AUTOMATIC PIPETTE	Mar 10, 1983	Substantially Equivalent	Micromedic Systems
K823364	COUNT-10 SYSTEM FOR STAND. URINALYSIS	Dec 15, 1982	Substantially Equivalent	V-Tech, Inc.
K822688	DIGITAL DILUTER/DISPENSERS	Nov 05, 1982	Substantially Equivalent	Hamilton Co.
K822208	CAVRO IQ-190 SAMPLE PROCESSOR	Aug 27, 1982	Substantially Equivalent	Cavro Scientific Instruments, Inc.
K821039	UNI-PUMP 200	May 03, 1982	Substantially Equivalent	Scientific Mfg. Industries, Inc.
K821034	SKATRON REPEATING DISPENSER	May 03, 1982	Substantially Equivalent	Skatron, Inc.
K821007	ECLIPSE	May 03, 1982	Substantially Equivalent	Scientific Software & Instrument Co.
K813426	MULTIWASH	Dec 22, 1981	Substantially Equivalent	Flow Laboratories, Inc.
K812983	DSD	Nov 10, 1981	Substantially Equivalent	Pm America, Inc.
K812782	DISPENSER ASPIRATOR DA 300	Oct 23, 1981	Substantially Equivalent	Pharmacia, Inc.
K812647	EMIT AUTO CAROUSEL	Oct 02, 1981	Substantially Equivalent	Syva Co.
K811696	IL #781, SEMI-AUTOMATED LOADER	Jul 01, 1981	Substantially Equivalent	Instrumentation Laboratory CO
K811001	MICROERMA SYSTEM	May 01, 1981	Substantially Equivalent	Dynatech Corp.
K810509	DIGITAL DISPENSING PUMP	Mar 06, 1981	Substantially Equivalent	Dynatech Corp.
K803092	MIC-BIOPLATE INOCULATOR	Dec 22, 1980	Substantially Equivalent	Pasco Laboratories, Inc.
K802520	CENTRIFICHEM PIPETTOR ACCURACY CALIB.	Nov 12, 1980	Substantially Equivalent	Union Carbide Corp.
K801913	MICROLAB M-MICROPROCESSOR DILUTER/DISP	Sep 26, 1980	Substantially Equivalent	Hamilton Co.
K801851	CENTRIFICHEM PIPETTOR 1000	Sep 16, 1980	Substantially Equivalent	Union Carbide Corp.
K801271	MODEL 4900 OFF-LINE PREPARATION SYSTEM	Jun 09, 1980	Substantially Equivalent	Pm America, Inc.
K801090	J.T. BAKER LSA 290 PIPETTER/DILUTER	Jun 09, 1980	Substantially Equivalent	J.T. Baker Chemical Co.
K801030	RIAUSE AUTO PROCESSOR	May 28, 1980	Substantially Equivalent	Electro-Nucleonics Laboratories, Inc.
K800606	MICROMEDIC AUTOMATIC DILUTER	Apr 16, 1980	Substantially Equivalent	Micromedic Systems
K800141	ACCUSTROKE PIPET	Feb 13, 1980	Substantially Equivalent	Beckman Instruments, Inc.
K800075	MICROMEDIC PUNCH & ELUTER	Feb 13, 1980	Substantially Equivalent	Micromedic Systems
K791324	MICROMEDIC APS2	Aug 28, 1979	Substantially Equivalent	Micromedic Systems
K790041	ACCESSORY KIT, CENTRIFICHEM	Feb 22, 1979	Substantially Equivalent	Union Carbide Corp.
K782130	MINI-DILUTER 2	Feb 15, 1979	Substantially Equivalent	Dynatech Laboratories, Inc.
K781883	DILUTER, LSA 290 PIPETTER	Dec 04, 1978	Substantially Equivalent	Kallestad Laboratories, Inc.
K781646	SRD-2	Oct 27, 1978	Substantially Equivalent	Dynatech Laboratories, Inc.
K781645	AUTODILUTER 2	Oct 27, 1978	Substantially Equivalent	Dynatech Laboratories, Inc.
K780912	ADJUSTABLE DISPENSOR	Jun 28, 1978	Substantially Equivalent	Oxford Laboratories, Inc.
K780882	DILUTER/DISPENSER	Jun 28, 1978	Substantially Equivalent	Innovative Medical Systems, Inc.
K780785	DILUTOR TRANSPORTER	Jun 14, 1978	Substantially Equivalent	Hyland Therapeutic Div., Travenol Laboratories
K780789	PERALISTIC PUMP MODEL 2000	Jun 13, 1978	Substantially Equivalent	Innovative Medical Systems, Inc.
K780208	ASPIRATOR, MANUEL	Mar 03, 1978	Substantially Equivalent	Dade, Baxter Travenol Diagnostics, Inc.
K770773	PIPETTE, DILUTING, MODEL ADP-30SD	Jul 11, 1977	Substantially Equivalent	G.D. Searle and Co.
K770772	PIPETTE, DISPENSING, MODEL ADP-30SD	Jul 11, 1977	Substantially Equivalent	G.D. Searle and Co.
K770307	MICRO/PETTOR, SMI	Apr 05, 1977	Substantially Equivalent	Lederle Laboratories
K770355	PIPETTOR W/DETIPPER	Mar 08, 1977	Substantially Equivalent	Sherwood Medical Industries
K770193	PIPETTOR, 400, CENTRIFICHEM SYSTEM	Mar 01, 1977	Substantially Equivalent	Universal Instruments Corp.
K770208	MOTORIZED OPERATOR FOR PIPETTING DEV.	Feb 28, 1977	Substantially Equivalent	Kensington Scientific
K761290	COMPU-PET 300	Feb 24, 1977	Substantially Equivalent	Nuclear Medical Laboratories, Inc.
K770210	ANALYTIX AUTO SAMPLE PREP. STA. 1600	Feb 14, 1977	Substantially Equivalent	G.D. Searle and Co.
K770013	PIPETTING DEVICES	Jan 25, 1977	Substantially Equivalent	Kensington Scientific