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: CHJ FDA class 2

Mercuric Thiocyanate, Colorimetry, Chloride

Clinical Chemistry

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The Mercuric Thiocyanate, Colorimetry, Chloride test system (product code CHJ) is an in-vitro diagnostic device used in clinical chemistry to measure chloride concentrations in serum or urine using a mercuric thiocyanate colorimetric method. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1170 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

510(k) Clearances

50+ matches

K Number

Device Name

Decision Date

Decision

Applicant

K010670

PICCOLO CHLORIDE TEST SYSTEM

Apr 26, 2001

Substantially Equivalent

ABAXIS, INC.

K945408

340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER

Feb 22, 1995

Substantially Equivalent

CATACHEM, INC.

K943006

CHLORIDE QVET

Dec 07, 1994

Substantially Equivalent

PRISMA SYSTEMS

K934136

OLYMPUS CHLORIDE REAGENT, MODIFICATION

Nov 05, 1993

Substantially Equivalent

OLYMPUS CORP.

K932528

OLYMPUS CHLORID REAGENT, MODIFIED

Sep 17, 1993

Substantially Equivalent

OLYMPUS CORP.

K925338

OLYMPUS CHLORIDE REAGENT

Dec 11, 1992

Substantially Equivalent

OLYMPUS CORP.

K922921

KING DIAGNOSTICS CHLORIDE REAGENT

Oct 05, 1992

Substantially Equivalent

KING DIAGNOSTICS, INC.

K923610

OLYMPUS CHLORIDE REAGENT

Oct 02, 1992

Substantially Equivalent

OLYMPUS CORP.

K923036

URINE CHLORIDE

Sep 09, 1992

Substantially Equivalent

HERAEUS KULZER, INC.

K911297

CHLORIDE REAGENT

Apr 16, 1991

Substantially Equivalent

INTERSECT SYSTEMS, INC.

K910133

CHLORIDE REAGENT (C1), CATALOG NO. DR0011/MODIFIED

Feb 27, 1991

Substantially Equivalent

OLYMPUS CORP.

K901500

CHLORIDE REAGENT FOR THE AU5000 CLINICAL LAB. ANA.

Jul 10, 1990

Substantially Equivalent

OLYMPUS CORP.

K892929

TECHNICON AXON TM SYSTEM ADDITIONAL ANALYTES

Jul 20, 1989

Substantially Equivalent

TECHNICON INSTRUMENTS CORP.

K890015

BIOTROL CHLORIDE

Feb 17, 1989

Substantially Equivalent

BIOTROL, USA, INC.

K884601

TECHNICON SYSTEMS RA-100/ASSIST CHLORIDE

Jan 27, 1989

Substantially Equivalent

TECHNICON INSTRUMENTS CORP.

K884706

CHLORIDE TEST (CL) ITEM #65659

Jan 11, 1989

Substantially Equivalent

EM DIAGNOSTIC SYSTEMS, INC.

K884013

ROCHE REAGENT FOR CHLORIDE

Dec 09, 1988

Substantially Equivalent

ROCHE DIAGNOSTIC SYSTEMS, INC.

K883386

CHLORIDE

Oct 06, 1988

Substantially Equivalent

TECH-CO, INC.

K881240

CHLORIDE REAGENT SET

Apr 28, 1988

Substantially Equivalent

TECH-NEAL SCIENTIFIC, INC.

K881200

CHLORIDE LIQUID STABLE REAGENT SET

Apr 28, 1988

Substantially Equivalent

MEDICAL ANALYSIS SYSTEMS, INC.

K875208

CHLORIDE CAT. # 152-17

Apr 18, 1988

Substantially Equivalent

DIAGNOSTIC CHEMICALS, LTD. (USA)

K874812

MULTICHEM CHLORIDE REAGENT S0933

Dec 18, 1987

Substantially Equivalent

SIMMLER, INC.

K870367

CHLORIDE REAGENT - THIOCYANATE METHOD

Aug 21, 1987

Substantially Equivalent

TRACE SCIENTIFIC LTD.

K872511

CHLORIDE FOR CONTINUOUS FLOW INSTRUMENTS

Jul 21, 1987

Substantially Equivalent

CATACHEM, INC.

K870630

CHLORIDE TEST

Apr 22, 1987

Substantially Equivalent

SCLAVO, INC.

K864713

CHLORIDE REAGENT

Dec 31, 1986

Substantially Equivalent

SIGMA DIAGNOSTICS, INC.

K863585

CHLORIDE PROCEDURE

Oct 16, 1986

Substantially Equivalent

DATA MEDICAL ASSOCIATES, INC.

K863620

RAICHEM(TM) CHLORIDE REAGENT

Sep 26, 1986

Substantially Equivalent

REAGENTS APPLICATIONS, INC.

K863061

CLOROFAST

Sep 09, 1986

Substantially Equivalent

J. D. ASSOC.

K861674

CHLORIDE PROCEDURE

Jul 01, 1986

Substantially Equivalent

DATA MEDICAL ASSOCIATES, INC.

K860662

AMRESCO FLOW PAC CHLORIDE REAGENT NO. 2256 & 2271

Mar 14, 1986

Substantially Equivalent

AMRESCO, INC.

K852169

CHLORIDE REAGENT

Aug 21, 1985

Substantially Equivalent

POINTE SCIENTIFIC, INC.

K852058

CHLORIDE ASSAY KIT

Jul 12, 1985

Substantially Equivalent

DIAGNOSTIC CHEMICALS, LTD. (USA)

K850935

CHLORIDE

Jun 10, 1985

Substantially Equivalent

DILAB, INC.

K850334

ROCHE REAGENT FOR CHLORIDE, FOR THE COBAS

Mar 14, 1985

Substantially Equivalent

ROCHE DIAGNOSTIC SYSTEMS, INC.

K843740

SCLAVO CHLORIDE TEST

Oct 05, 1984

Substantially Equivalent

SCLAVO, INC.

K842011

CHLORIDE TEST KIT

Jun 22, 1984

Substantially Equivalent

MALLINCKRODT CRITICAL CARE

K841047

PARAMAX CHLORIDE REAGENT

Apr 19, 1984

Substantially Equivalent

AMERICAN DADE

K834333

FLOW-PAC CHLORIDE REAGENT SET

Feb 21, 1984

Substantially Equivalent

AMERICAN RESEARCH PRODUCTS CO.

K832438

CHLORIDE REAGENT SET

Jan 20, 1984

Substantially Equivalent

AMRESCO, INC.

K833746

TECH. RA-1000 SYS SERUM CHLORIDE

Jan 13, 1984

Substantially Equivalent

TECHNICON INSTRUMENTS CORP.

K833166

PROCEDURE 460 FOR DETERM. OF CHLORIDE

Oct 28, 1983

Substantially Equivalent

SIGMA CHEMICAL CO.

K820235

TPTZ CHLORIDE

Feb 12, 1982

Substantially Equivalent

AMERICAN MONITOR CORP.

K803013

CHLORIDE/TCO2 ANALYZER REAGENTS

Jan 02, 1981

Substantially Equivalent

LABORATORY PRODUCTS, INC.

K802163

CHLORIDE COLOR & CHLORIDE SAMPLE DILUENT

Oct 10, 1980

Substantially Equivalent

PANMED, INC.

K800683

REAGENT FOR DETERM. CHLORIDE IN HUMAN/SM

May 28, 1980

Substantially Equivalent

DIAGNOSTIC SOLUTIONS, INC.

K792605

CHLORIDE REAGENT

Jan 16, 1980

Substantially Equivalent

GILFORD DIAGNOSTICS

K792531

SANDARE CHLORIDE PROCEDURE

Jan 11, 1980

Substantially Equivalent

SANDARE CHEMICAL CO., INC.

K792400

ELVI CHLORIDE

Dec 07, 1979

Substantially Equivalent

VOLU SOL MEDICAL INDUSTRIES

K781460

CHLORIDE REAGENT

Oct 10, 1978

Substantially Equivalent

ANALYTICAL & RESEARCH CHEMICALS, INC.

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.

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