Product Code: CHJ FDA class 2 21 CFR 862.1170

Mercuric Thiocyanate, Colorimetry, Chloride

Clinical Chemistry

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.

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510(k)s

FEI Numbers

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Unique Applicants

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Basic Information

Product Code: CHJ
Device Class: FDA class 2
Regulation Number: 862.1170
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 1

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 53 510(k) clearances via K numbers.

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.
K781635	CHLORIDE TEST SET, CAT.# 0210	Oct 03, 1978	Substantially Equivalent	Stanbio Laboratory
K770752	REAGENT, CHLORIDE, COULTER	Jun 17, 1977	Substantially Equivalent	Coulter Electronics, Inc.
K770450	CHLORIDE PROCEDURE, TEKPOINT DIRECT	May 03, 1977	Substantially Equivalent	Icn Pharmaceuticals, Inc.