Tool · 510(k)

510(k) Predicate Finder

Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

Product Code: JTC FDA class 1

Device, Microtiter Diluting/Dispensing

Microbiology

View full classification →

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.

510(k) Clearances

50+ matches

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.

K891765

GENETIC SYSTEMS PIPETTOR/DILUTOR

May 01, 1989

Substantially Equivalent

GENETIC SYSTEMS CORP.

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.

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.

K851019

MIC-CONCEPT INOCULUM SEED TRAY

Mar 29, 1985

Substantially Equivalent

MICROTECH MEDICAL SYSTEMS, INC.

K851020

MIC-CONCEPT INOCULATOR

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.

K844891

SLT 225 WASHER/DISPENSER FOR MICRO TITERPLATES

Feb 25, 1985

Substantially Equivalent

SLT LABINSTRUMENTS, INC.

K844893

SLT 223 DISPENSER FOR MICROTITERPLATES

Feb 25, 1985

Substantially Equivalent

SLT LABINSTRUMENTS, INC.

K844552

BIO-STAT III PLATE WASHER

Jan 30, 1985

Substantially Equivalent

WHITTAKER BIOPRODUCTS, INC.

K844568

TITERTEK DULUTER/DISPENSER 78-640-00

Jan 30, 1985

Substantially Equivalent

FLOW LABORATORIES, 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.

K831640

WASHER 6000 MICRO-C LISA SYSTEM

Aug 08, 1983

Substantially Equivalent

ORGANON TEKNIKA CORP.

K832203

MULTI-TITER DISPENSER

Aug 08, 1983

Substantially Equivalent

HAMILTON CO.

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

BIO MERIEUX, 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.

K803242

SEROCLUSTER EIA PLATES

Jan 28, 1981

Substantially Equivalent

CORNING COSTAR CORP.

K803243

SEROCLUSTER FLEXIBLE VINYL U & V PL.

Jan 28, 1981

Substantially Equivalent

CORNING COSTAR CORP.

What is a Predicate Device?

A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

Popular Product Codes

Commonly searched

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