Product Code: JTC FDA class 1 21 CFR 866.2500

Device, Microtiter Diluting/Dispensing

Microbiology

Device, Microtiter Diluting/Dispensing is a laboratory device used to perform accurate serial dilutions and liquid dispensing into microtiter plate formats, supporting a wide range of microbiological and biochemical assays including antimicrobial susceptibility testing. It is classified as FDA Class 1, posing the lowest risk and subject to general controls only. The product code is JTC, regulated under 21 CFR 866.2500, and falls within the Microbiology medical specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: JTC
Device Class: FDA class 1
Regulation Number: 866.2500
Medical Specialty: Microbiology
Review Panel: MI
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 66 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K924907	FILTERMATE UNIVERSAL HARVESTER	Dec 01, 1992	Substantially Equivalent	Packard Instrument Co., Inc.
K901808	MICROMATE 196 MODEL A961960	Jun 20, 1990	Substantially Equivalent	Packard Instrument Co., Inc.
K894645	IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM	Oct 17, 1989	Substantially Equivalent	Dynatech Laboratories, Inc.
K892369	MULTI-PROBE HEAD PLUS	Jun 02, 1989	Substantially Equivalent	Hamilton Co.
K891768	GENETIC SYSTEMS MICROPLATE WASHER	May 01, 1989	Substantially Equivalent	Genetic Systems Corp.
K891766	GENETIC SYSTEMS MICROPLATE STRIP WASHER	May 01, 1989	Substantially Equivalent	Genetic Systems Corp.
K891765	GENETIC SYSTEMS PIPETTOR/DILUTOR	May 01, 1989	Substantially Equivalent	Genetic Systems Corp.
K884695	WASHER 500 MICROELISA SYSTEM	Dec 13, 1988	Substantially Equivalent	Organon Teknika Corp.
K884125	BIO-TEK AUTOMATED MICROPLATE WASHER MODEL EL403	Dec 02, 1988	Substantially Equivalent	Bio-Tek Instruments, Inc.
K874598	DYNATECH MR 250 MANUAL MICROELISA READER	Nov 20, 1987	Substantially Equivalent	Dynatech Laboratories, Inc.
K873542	MICROPLATE AUTO-WASHER (MOTORIZED STAGE)	Sep 23, 1987	Substantially Equivalent	Genetic Systems Corp.
K871945	MICROLAB AT	May 29, 1987	Substantially Equivalent	Hamilton Co.
K863423	CODE-A-WELL SERIES 1-1000 AND SERIES 1-1100	Sep 16, 1986	Substantially Equivalent	Plastic Injectors, Inc.
K863374	CODE-A-WELL SERIES 1-600, 1-625	Sep 11, 1986	Substantially Equivalent	Plastic Injectors, Inc.
K862802	MULTI-CHANNEL MICROPIPETTES	Aug 01, 1986	Substantially Equivalent	Dynatech Laboratories, Inc.
K862066	TITERTEK MICROPLATE WASHER S-12	Jun 05, 1986	Substantially Equivalent	Flow Laboratories, Inc.
K860617	POLYPET	Mar 03, 1986	Substantially Equivalent	Instrumed, Inc.
K853920	BIO-TEK EL 401 HANDHELD MICROPLATE WASHER	Oct 22, 1985	Substantially Equivalent	Bio-Tek Instruments, Inc.
K853380	SPR 2 AUTODILUTER	Sep 12, 1985	Substantially Equivalent	Scientific Sales Intl., Inc.
K851020	MIC-CONCEPT INOCULATOR	Mar 29, 1985	Substantially Equivalent	Microtech Medical Systems, Inc.
K851019	MIC-CONCEPT INOCULUM SEED TRAY	Mar 29, 1985	Substantially Equivalent	Microtech Medical Systems, Inc.
K850908	TITERTEK MICROITTRATION EQUIP. HANDIWASH 110 12CHA	Mar 25, 1985	Substantially Equivalent	Flow Laboratories, Inc.
K850249	BIO-TEK AUTOMATED MICROPLATE WASHER EL402	Mar 13, 1985	Substantially Equivalent	Bio-Tek Instruments, Inc.
K850371	INTIWASH MANUAL MICROPLATE WASHER	Mar 11, 1985	Substantially Equivalent	Inti Corp.
K844893	SLT 223 DISPENSER FOR MICROTITERPLATES	Feb 25, 1985	Substantially Equivalent	Slt Labinstruments, Inc.
K844891	SLT 225 WASHER/DISPENSER FOR MICRO TITERPLATES	Feb 25, 1985	Substantially Equivalent	Slt Labinstruments, Inc.
K844568	TITERTEK DULUTER/DISPENSER 78-640-00	Jan 30, 1985	Substantially Equivalent	Flow Laboratories, Inc.
K844552	BIO-STAT III PLATE WASHER	Jan 30, 1985	Substantially Equivalent	Whittaker Bioproducts, Inc.
K844500	TITERTEK MICROPLATE WASHER 120	Jan 22, 1985	Substantially Equivalent	Flow Laboratories, Inc.
K843272	T.I.M.E. DISPENSER	Sep 14, 1984	Substantially Equivalent	Dynatech Laboratories, Inc.
K842848	CODE-A-WELL 350 MICROTITRATION STRIPS	Sep 07, 1984	Substantially Equivalent	Plastic Injectors, Inc.
K831462	API UNISCEPT PLUS 140 INOCULATOR	Aug 12, 1983	Substantially Equivalent	Analytical Products, Inc.
K832203	MULTI-TITER DISPENSER	Aug 08, 1983	Substantially Equivalent	Hamilton Co.
K831640	WASHER 6000 MICRO-C LISA SYSTEM	Aug 08, 1983	Substantially Equivalent	Organon Teknika Corp.
K831644	PIPETTE 12 CHANNEL	Aug 01, 1983	Substantially Equivalent	Organon Teknika Corp.
K831341	API UNISCEPT PLUS AUTOINOCULATOR	Jun 02, 1983	Substantially Equivalent	Analytical Products, Inc.
K830059	MUELLER HINTON W/50% SHEEP BLOOD	Feb 09, 1983	Substantially Equivalent	bioMerieux, Inc.
K823137	OCTAPETTES	Dec 03, 1982	Substantially Equivalent	Corning Costar Corp.
K823218	DISPOSABLE DISPENSE MANIFOLD	Nov 16, 1982	Substantially Equivalent	Dynatech Laboratories, Inc.
K821961	96 WELL DISPENSER	Jul 22, 1982	Substantially Equivalent	Skatron, Inc.
K820992	MICROPLATE WASHING DEVICE	May 03, 1982	Substantially Equivalent	Skatron, Inc.
K820821	MIC-2000 PLUS, 96 CHANNEL DISPENSER	Apr 14, 1982	Substantially Equivalent	Dynatech Corp.
K812860	IMMUNOASSAY PLATE	Oct 26, 1981	Substantially Equivalent	Skatron, Inc.
K812818	TITERTEK AUTODROP	Oct 23, 1981	Substantially Equivalent	Flow Laboratories, Inc.
K810719	REPLICA PLATER	Apr 01, 1981	Substantially Equivalent	Dynatech Corp.
K810659	AUTODILUTER III	Mar 31, 1981	Substantially Equivalent	Dynatech Corp.
K810229	SCEPTOR SYSTEM AUTOMATED MODEL 216	Feb 09, 1981	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K803244	ASSAY STRIPS	Feb 02, 1981	Substantially Equivalent	Corning Costar Corp.
K810039	MIC-2000 INOCULUM TRAY LID	Jan 28, 1981	Substantially Equivalent	Dynatech Corp.
K803243	SEROCLUSTER FLEXIBLE VINYL U & V PL.	Jan 28, 1981	Substantially Equivalent	Corning Costar Corp.
K803242	SEROCLUSTER EIA PLATES	Jan 28, 1981	Substantially Equivalent	Corning Costar Corp.
K810022	SRD III	Jan 26, 1981	Substantially Equivalent	Dynatech Corp.
K803252	MICROMEDIC REAGENT DISPENSER	Jan 12, 1981	Substantially Equivalent	Micromedic Systems
K802857	IMMULON REMOVAWELL STRIPS #011-010-6301	Dec 11, 1980	Substantially Equivalent	Dynatech Corp.
K801305	HIPPURATE DISK	Jul 21, 1980	Substantially Equivalent	Remel Co.
K801437	DISPENSING SEROLOGICAL PIPET	Jul 14, 1980	Substantially Equivalent	Amt Corp.
K800989	DYNAWASHER II	Jun 02, 1980	Substantially Equivalent	Dynatech Laboratories, Inc.
K800240	SEROCLUSTER U AND V	Feb 13, 1980	Substantially Equivalent	Corning Costar Corp.
K790974	MIC-2000 INOCULATOR TEMPLATE	Jun 20, 1979	Substantially Equivalent	Dynatech Laboratories, Inc.
K790971	MIC-2000 QUAD INOCULUM TRAY	Jun 20, 1979	Substantially Equivalent	Dynatech Laboratories, Inc.
K790957	HISTO-DISPENSER	Jun 15, 1979	Substantially Equivalent	Dynatech Laboratories, Inc.
K790956	HISTO-OILER	Jun 15, 1979	Substantially Equivalent	Dynatech Laboratories, Inc.
K790076	INOCULATOR, MIC-2000 DISPOSABLE	Feb 01, 1979	Substantially Equivalent	Dynatech Laboratories, Inc.
K781802	WASHER SYSTEM, MICROELISA	Dec 20, 1978	Substantially Equivalent	Metrix Teknika, Inc.
K781942	MINIWASH	Dec 04, 1978	Substantially Equivalent	Dynatech Laboratories, Inc.
K761149	MODEL 203 DISPENSER	Dec 09, 1976	Substantially Equivalent	Beckman Instruments, Inc.