Product Code: JQP FDA class 1 21 CFR 862.2100

Calculator/Data Processing Module, For Clinical Use

Clinical Chemistry

The Calculator/Data Processing Module, For Clinical Use is a clinical laboratory device or software module used to perform calculations and process data generated during clinical chemistry and other diagnostic testing, including computation of results, reference ranges, and quality control statistics to support accurate reporting of patient test results. This device is FDA Class 1, the lowest risk category, requiring only general controls and no premarket notification. It carries product code JQP and is regulated under 21 CFR 862.2100, within the Clinical Chemistry medical specialty.

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510(k)s

FEI Numbers

115

Registration Numbers

116

Unique Applicants

Years Active

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Basic Information

Product Code: JQP
Device Class: FDA class 1
Regulation Number: 862.2100
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 78 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K113007	BIONIME DIABETES MANAGEMENT SYSTEM VI.0	Feb 27, 2012	Substantially Equivalent	Bionime Corporation
K983468	FASTTAKE ADAPTER, MODEL # P/N 020-072-01	Dec 17, 1998	Substantially Equivalent	Selfcare, Inc.
K964460	THE ROBOLITE	Jan 24, 1997	Substantially Equivalent	Shai Syg Motion and Innovations, Ltd.
K953652	PRENVAL I	Sep 15, 1995	Substantially Equivalent	Base Ten Systems, Inc.
K934111	MR7000 WITH TIME MANAGER SOFTWARE (TMS)	Nov 02, 1994	Substantially Equivalent	Dynatech Laboratories, Inc.
K923316	EXPRESSO CARTRIDGE	Feb 23, 1993	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K893838	MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZER	Aug 31, 1989	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K892060	CYBERLAB HIGH VOLUME DRUG TESTING SYSTEM	Aug 10, 1989	Substantially Equivalent	Syva Co.
K885292	COBAS MFC	Mar 22, 1989	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K881194	RIA-QUICK	Jun 01, 1988	Substantially Equivalent	Quantitative Technologies, Inc.
K871853	V-MARC 88A COMPUTER	Jul 16, 1987	Substantially Equivalent	V.Marc, A Div. of Pictorial, Inc.
K871339	KALLESTAD QM300 PROTEIN ANALYSIS SYSTEM	May 15, 1987	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K864557	710 PLUS	Feb 25, 1987	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K861844	GLUCOFACTS DATA MANAGEMENT SYSTEM	Aug 12, 1986	Substantially Equivalent	Miles Laboratories, Inc.
K861779	GLUCOFACTS DATA PRINTER	Aug 08, 1986	Substantially Equivalent	Miles Laboratories, Inc.
K861778	CLINIFACTS 200 DATA MANAGEMENT SYSTEM	Jul 02, 1986	Substantially Equivalent	Miles Laboratories, Inc.
K861412	DIRECT READOUT MODULE ACCESSORY	May 23, 1986	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K854265	SIMULATOR	Mar 18, 1986	Substantially Equivalent	Cygnus of South Florida, Inc.
K853026	BIOVATION MAX DATA MANAGEMENT SYSTEM	Aug 02, 1985	Substantially Equivalent	Biovation, Inc.
K851321	ATAC 2000 CHEMISTRY ANALYZER	Apr 25, 1985	Substantially Equivalent	Turpen Laboratory Systems, Inc.
K850659	SYVA 700 SYSTEM ACCESSORIES-CLINICAL CHEM ANALYZER	Apr 01, 1985	Substantially Equivalent	Syva Co.
K844907	CLINIFACTS 10 DATA MANAGEMENT SYSTEM	Jan 18, 1985	Substantially Equivalent	Miles Laboratories, Inc.
K843365	ISO-DATA IMMUNOASSAY NETWORK SYSTEM	Sep 27, 1984	Substantially Equivalent	Iso-Data, Inc.
K842401	CHEMISTRY CONSOLE	Sep 04, 1984	Substantially Equivalent	Biovation, Inc.
K831830	LYRIS MODULAR INFO SYSTEM	Jun 25, 1984	Substantially Equivalent	Biovation, Inc.
K834490	GELSCAN SOFTWARE 2190	May 01, 1984	Substantially Equivalent	Lkb Instruments, Inc.
K840502	CATS-CLINICAL LAB COMPUTER SOFTWARE-	Apr 04, 1984	Substantially Equivalent	Precision Technology, Inc.
K834300	HYBRITECH DATA STATION	Feb 21, 1984	Substantially Equivalent	Hybritech, Inc.
K831838	LABORATORY DATA MGMT SYSTEM SDMS	Jan 24, 1984	Substantially Equivalent	Vickers America Medical Corp.
K833353	ACLAIM-QAP IBM PERSONAL COMPUTER EDT	Dec 22, 1983	Substantially Equivalent	American Dade
K832746	DUPONT LINEARIZATION MODULE	Nov 25, 1983	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K832760	RIA SOFTWARE	Oct 14, 1983	Substantially Equivalent	Kemble Instruments, Inc.
K831574	BLOOD GAS QUALITY CONTROL SOFT-86000F	Oct 14, 1983	Substantially Equivalent	Computermate, Inc.
K830296	CORNING 102 PRINTER	Mar 25, 1983	Substantially Equivalent	Corning Medical & Scientific
K823785	API MDS*	Jan 09, 1983	Substantially Equivalent	Analytical Products, Inc.
K823679	NML 6000 CT	Jan 07, 1983	Substantially Equivalent	Nuclear Medical Laboratories, Inc.
K822778	BLOOD GAS EXPER. SYSTEM 8700	Dec 03, 1982	Substantially Equivalent	Exper Corp., Inc.
K823110	QAP MICROCOMPUTER SYSTEM	Nov 16, 1982	Substantially Equivalent	American Dade
K822932	EMIT CLINICAL PROCESSOR #CP-5000	Nov 05, 1982	Substantially Equivalent	Syva Co.
K822860	RIA SSIST TI-59 MAGNETIC CARD PROGRAMS	Oct 27, 1982	Substantially Equivalent	Ventrex Laboratories, Inc.
K822381	SYVA LAB PROCESSOR 6000	Aug 27, 1982	Substantially Equivalent	Syva Co.
K822146	CORNING 101 PRINTER	Aug 05, 1982	Substantially Equivalent	Corning Medical & Scientific
K821807	AMERIFLOUR FLUOROMETER	Jul 02, 1982	Substantially Equivalent	American Diagnostic Corp.
K821531	EMIT TIMER UNIT #100	Jun 11, 1982	Substantially Equivalent	Syva Co.
K821058	715 DELTA TERMINAL	May 03, 1982	Substantially Equivalent	Corning Medical & Scientific
K820721	COMPUTERIZED INTERPRETATION OF ARTERIAL	Apr 01, 1982	Substantially Equivalent	Philip R. Corsello, M.D.
K820427	IL 8060 DATA MANAGEMENT SYSTEM	Mar 11, 1982	Substantially Equivalent	Instrumentation Laboratory CO
K812604	BIOVATION URINALYSIS REPORTER	Oct 02, 1981	Substantially Equivalent	Biovation, Inc.
K810968	BCD-HPP41C INTERFACE	Apr 23, 1981	Substantially Equivalent	Dynatech Corp.
K810631	DPM CALCULATOR	Mar 27, 1981	Substantially Equivalent	Iso-Data, Inc.
K803312	MICROMEDIC AUTOMATIC COMPUTING CENTER	Feb 04, 1981	Substantially Equivalent	Micomedic Systems
K810063	AUTOMATIC BIOCHEMICAL ANALYZER	Jan 26, 1981	Substantially Equivalent	Acculab
K802594	BECKMAN DP-5500 DATA REDUCTION SYSTEM	Nov 12, 1980	Substantially Equivalent	Beckman Instruments, Inc.
K802471	CHEMTROLER	Nov 12, 1980	Substantially Equivalent	Fletcher Flora Computer Products, Inc.
K802251	SP 120 SOPHISTICATE	Oct 23, 1980	Substantially Equivalent	Vickers America Medical Corp.
K801664	SERALYZER GLUCOSE TEST MODULE	Aug 20, 1980	Substantially Equivalent	Miles Laboratories, Inc.
K801438	CENTRIFICHEM SYSTEM MANAGER	Jul 28, 1980	Substantially Equivalent	Union Carbide Corp.
K801210	BIOSTATOR PRINTER/PLOTTER	Jun 17, 1980	Substantially Equivalent	Miles Laboratories, Inc.
K801167	CENTRIFICHEM SYSTEM 400	Jun 09, 1980	Substantially Equivalent	Union Carbide Corp.
K801091	K 750 COMPUTER/DATA PROCESSOR	Jun 09, 1980	Substantially Equivalent	J.T. Baker Chemical Co.
K801131	IL88640 & 88641 CASSETTE-TAPE PROGRAM	May 23, 1980	Substantially Equivalent	Instrumentation Laboratory CO
K800724	AMES LAB MANAGEMENT SYSTEM	Apr 16, 1980	Substantially Equivalent	Miles Laboratories, Inc.
K800282	DATA MANAGEMENT SYSTEM IL MODEL 775	Mar 05, 1980	Substantially Equivalent	Instrumentation Laboratory CO
K800242	MICRO MEDICAL DATA SYSTEM II	Mar 03, 1980	Substantially Equivalent	Micro/Tel., Inc.
K800241	MICRO MEDICAL DATA SYSTEM	Feb 26, 1980	Substantially Equivalent	Micro/Tel., Inc.
K792158	3388 REPORTING INTEGRATOR	Nov 16, 1979	Substantially Equivalent	Hewlett-Packard Co.
K792129	EMIT CLINICAL PROCESSOR-CP 5000	Nov 13, 1979	Substantially Equivalent	Syva Co.
K790543	THE ABBOTT EXECUTIVE	May 03, 1979	Substantially Equivalent	Abbott Laboratories
K790336	UNION CARBIDE CORP. COMPUTER INTERFACE	Apr 04, 1979	Substantially Equivalent	Union Carbide Corp.
K782052	PROCESSOR, K750 COMPUTER/DATA	Jan 17, 1979	Substantially Equivalent	Kallestad Laboratories, Inc.
K781081	EMIT MCA PROGRAM TAPE	Sep 27, 1978	Substantially Equivalent	Instrumentation Laboratory CO
K781173	COMPUTER INTERFACE IL 814	Sep 14, 1978	Substantially Equivalent	Instrumentation Laboratory CO
K781217	DATA TERMINAL MODEL 722	Aug 21, 1978	Substantially Equivalent	Corning Medical & Scientific
K780881	EMIT CLINICAL PROCESSOR - CP 5000	Jun 22, 1978	Substantially Equivalent	Syva Co.
K770877	DATA REDUCTION SYSTEM, DP-3000	Jul 21, 1977	Substantially Equivalent	Beckman Instruments, Inc.
K770671	CALCULATOR, ENZYME, TURNER	Jun 27, 1977	Substantially Equivalent	Turner Assoc.
K761063	GAMMACORD II CALCULATOR INTERFACE	Dec 02, 1976	Substantially Equivalent	Miles Laboratories, Inc.
K760739	ACA DATA MATE ACCESSORY	Nov 16, 1976	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.