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: JJQ FDA class 1

Colorimeter, Photometer, Spectrophotometer For Clinical Use

Clinical Chemistry

View full classification →

This device is a colorimeter, photometer, or spectrophotometer intended for clinical laboratory use to measure the absorbance or transmittance of light by patient specimens or reaction products, enabling quantitative determination of biochemical analytes based on color intensity. It is classified as FDA Class 1 and is subject only to general controls with no premarket notification required. The product code is JJQ, regulated under 21 CFR 862.2300, and assigned to the Clinical Chemistry medical specialty.

510(k) Clearances

50+ matches

K Number

Device Name

Decision Date

Decision

Applicant

K013371

UBIT-IR300 INFRARED SPECTROMETRY SYSTEM

Dec 21, 2001

Substantially Equivalent

OTSUKA PHARMACEUTICAL CO., LTD.

K980120

DIGENE DML 2000 MICROPLATE LUMINOMETER

Feb 06, 1998

Substantially Equivalent

DIGENE CORP.

K973938

ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER

Feb 04, 1998

Substantially Equivalent

SFRI, INC.

K974762

STAT TRACKS

Jan 28, 1998

Substantially Equivalent

AWARENESS TECHNOLOGY, INC.

K962113

ANTHOS PHACTS VERSION MICROPLATE READER

Nov 05, 1996

Substantially Equivalent

COLUMBIA BIOSCIENCE, INC.

K961183

CBI 7520 READER

Aug 02, 1996

Substantially Equivalent

COLUMBIA BIOSCIENCE, INC.

K962166

ORIGEN ANALYZER

Jul 31, 1996

Substantially Equivalent

IGEN, INC.

K955077

ANTHOS 2010 READER

Dec 04, 1995

Substantially Equivalent

ANTHOS LABTEC, INC.

K953710

ELX808 AUTOMATED MICROPLATE READERS

Oct 25, 1995

Substantially Equivalent

BIO-TEK INSTRUMENTS, INC.

K953572

ELX800UV

Oct 19, 1995

Substantially Equivalent

BIO-TEK INSTRUMENTS, INC.

K953005

BILI-METER

Sep 28, 1995

Substantially Equivalent

OLYMPIC MEDICAL CORP.

K950029

5STRATEC SL 300 LIA-MAT

Aug 02, 1995

Substantially Equivalent

NICHOLS INSTITUTE DIAGNOSTICS

K940486

DIGENE DCR-1 LUMINOMETER

Apr 18, 1995

Substantially Equivalent

DIGENE DIAGNOSTICS, INC.

K942361

WHITSOFT

Apr 04, 1995

Substantially Equivalent

BIOWHITTAKER MOLECULAR APPLICATIONS, INC.

K942250

BIOWHITTAKER CARTRIDGE SOFTWARE FOR EIA-400 PLATE READER

Apr 04, 1995

Substantially Equivalent

BIOWHITTAKER MOLECULAR APPLICATIONS, INC.

K942245

BIOWHITTAKER 2001 MICROPLATE READER FIRMWARE

Apr 03, 1995

Substantially Equivalent

BIOWHITTAKER MOLECULAR APPLICATIONS, INC.

K950104

ELX800 AND EL800 AUTOMATED MICROPLATE READERS

Mar 21, 1995

Substantially Equivalent

BIO-TEK INSTRUMENTS, INC.

K942923

CERES 900C & CERES UV900C

Feb 06, 1995

Substantially Equivalent

BIO-TEK INSTRUMENTS, INC.

K943454

PLATO 3300/1300

Jan 09, 1995

Substantially Equivalent

ROSYS, INC.

K935983

MICROREADER 4

Dec 09, 1994

Substantially Equivalent

HYPERION, INC.

K943595

SERUM/URINE APPLI ILAB(TM) CLINICAL CHEMISTRY SYSTEM

Nov 28, 1994

Substantially Equivalent

INSTRUMENTATION LABORATORY CO.

K941050

DUPONT ACA STAR

Nov 10, 1994

Substantially Equivalent

DUPONT MEDICAL PRODUCTS

K943701

MRX MICROPLATE READER

Oct 20, 1994

Substantially Equivalent

DYNATECH LABORATORIES, INC.

K932778

BOEHRINGER MANNHEIM ES 300 AL(AUTOLOADER) ANALYZER

Nov 17, 1993

Substantially Equivalent

BOEHRINGER MANNHEIM CORP.

K932467

ILAB 900/1800 CLINICAL CHEMISTRY SYSTEM

Nov 05, 1993

Substantially Equivalent

INSTRUMENTATION LABORATORY CO.

K921536

ACCULYTE CHEMILUMINESCENCE ANALYZER

Oct 12, 1993

Substantially Equivalent

LABORATORY TECHNOLOGIES, INC.

K931907

ANTHOS HT READERS, INCLUDING THE ANTHOS HT II&III

Sep 29, 1993

Substantially Equivalent

ANTHOS LABTEC INSTRUMENTS

K925625

OMNI

Aug 19, 1993

Substantially Equivalent

BIO-TEK INSTRUMENTS, INC.

K925935

OLYMPUS REPLY CLINICAL CHEMISTRY ANALYZER

Apr 22, 1993

Substantially Equivalent

OLYMPUS CORP.

K923844

LYRIS 100/120 LABORATORY INFORMATION SYSTEM

Dec 11, 1992

Substantially Equivalent

BIOVATION, INC.

K925203

TECHNICON CHEM 1(R)/CHEM 1+(TM) SOFTWARE VER 11.1

Nov 25, 1992

Substantially Equivalent

HERAEUS KULZER, INC.

K923158

LUMICO ANALYZER SA-300

Nov 17, 1992

Substantially Equivalent

MARUZEN PETROCHEMICAL CO., LTD.

K922329

BERTHOLD LB 954

Nov 16, 1992

Substantially Equivalent

EG&G BERTHOLD ANALYTICAL INSTRUMENTS, INC.

K922976

LB 9502- CLINILUMAT, LB 953 - AUTO-CLIMILUMAT

Nov 16, 1992

Substantially Equivalent

EG&G BERTHOLD ANALYTICAL INSTRUMENTS, INC.

K923456

MICROLITE MICROTITER PLATE LUMINOMETER ML3000

Oct 13, 1992

Substantially Equivalent

DYNATECH LABORATORIES, INC.

K922081

LABOTECH AUTOMATED MICROTITER ANALYZER

Sep 02, 1992

Substantially Equivalent

INNOVATIVE MEDICAL SYSTEMS, INC.

K921180

COBAS CORE IMMUNOCHEMISTRY SYSTEM

Jul 28, 1992

Substantially Equivalent

ROCHE DIAGNOSTIC SYSTEMS, INC.

K915896

MICROLITE MICROTITER PLATE LUMINOMETER ML2250/MODI

May 04, 1992

Substantially Equivalent

DYNATECH LABORATORIES, INC.

K915690

SLT 340 ATTC

Apr 22, 1992

Substantially Equivalent

SLT LABINSTRUMENTS, INC.

K915689

SLT SPECTRA

Apr 22, 1992

Substantially Equivalent

SLT LABINSTRUMENTS, INC.

K920914

MP/S SINGLE WAVELENGTH MINI PHOTOMETER

Mar 23, 1992

Substantially Equivalent

ARTEL, INC.

K915113

ENCORE

Mar 18, 1992

Substantially Equivalent

HERAEUS KULZER, INC.

K915680

AMERLITE PROCESSING CENTER

Mar 11, 1992

Substantially Equivalent

EASTMAN KODAK COMPANY

K914906

AUTO EIA MICROPLATE READ MODEL CERES 900 W/VAR OPT

Nov 27, 1991

Substantially Equivalent

BIO-TEK INSTRUMENTS, INC.

K913590

MICROLITE ML 1000 MICROTITER PLATE LUMINOMETER

Oct 25, 1991

Substantially Equivalent

DYNATECH LABORATORIES, INC.

K914202

BARTELS PRIMA SYSTEM ADVANCED SCREENING CARTRIDGE

Oct 11, 1991

Substantially Equivalent

BAXTER DIAGNOSTICS, INC.

K913840

MICROTAK PLUS

Sep 30, 1991

Substantially Equivalent

SYVA CO.

K913295

OPUS(R) PLUS ANALYZER

Sep 11, 1991

Substantially Equivalent

PB DIAGNOSTIC SYSTEMS, INC.

K912368

IMX SELECT ANALYZER

Sep 11, 1991

Substantially Equivalent

ABBOTT LABORATORIES

K910806

METROLAB MODEL 1500

Aug 30, 1991

Substantially Equivalent

LABORATORIO RODRIGUEZ CORSWANT S.R.L.

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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