Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

CHJ — Predicate Candidate Screening

53 FDA 510(k) clearances under this product code; the 50 most recent screened below.

52 daysmedian FDA review time

111 days90th percentile

53clearances measured

K-number	Device	Applicant	Decided	Review days
K010670	PICCOLO CHLORIDE TEST SYSTEM	Abaxis, Inc.	2001-04-26	51
K945408	340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER	Catachem, Inc.	1995-02-22	111
K943006	CHLORIDE QVET	Prisma Systems	1994-12-07	167
K934136	OLYMPUS CHLORIDE REAGENT, MODIFICATION	Olympus Corp.	1993-11-05	78
K932528	OLYMPUS CHLORID REAGENT, MODIFIED	Olympus Corp.	1993-09-17	148
K925338	OLYMPUS CHLORIDE REAGENT	Olympus Corp.	1992-12-11	52
K922921	KING DIAGNOSTICS CHLORIDE REAGENT	King Diagnostics, Inc.	1992-10-05	110
K923610	OLYMPUS CHLORIDE REAGENT	Olympus Corp.	1992-10-02	81
K923036	URINE CHLORIDE	Heraeus Kulzer, Inc.	1992-09-09	82
K911297	CHLORIDE REAGENT	Intersect Systems, Inc.	1991-04-16	22
K910133	CHLORIDE REAGENT (C1), CATALOG NO. DR0011/MODIFIED	Olympus Corp.	1991-02-27	49
K901500	CHLORIDE REAGENT FOR THE AU5000 CLINICAL LAB. ANA.	Olympus Corp.	1990-07-10	103
K892929	TECHNICON AXON TM SYSTEM ADDITIONAL ANALYTES	Technicon Instruments Corp.	1989-07-20	90
K890015	BIOTROL CHLORIDE	Biotrol, USA, Inc.	1989-02-17	45
K884601	TECHNICON SYSTEMS RA-100/ASSIST CHLORIDE	Technicon Instruments Corp.	1989-01-27	85
K884706	CHLORIDE TEST (CL) ITEM #65659	Em Diagnostic Systems, Inc.	1989-01-11	63
K884013	ROCHE REAGENT FOR CHLORIDE	Roche Diagnostic Systems, Inc.	1988-12-09	78
K883386	CHLORIDE	Tech-Co, Inc.	1988-10-06	57
K881200	CHLORIDE LIQUID STABLE REAGENT SET	Medical Analysis Systems, Inc.	1988-04-28	38
K881240	CHLORIDE REAGENT SET	Tech-Neal Scientific, Inc.	1988-04-28	37
K875208	CHLORIDE CAT. # 152-17	Diagnostic Chemicals, Ltd. (Usa)	1988-04-18	122
K874812	MULTICHEM CHLORIDE REAGENT S0933	Simmler, Inc.	1987-12-18	24
K870367	CHLORIDE REAGENT - THIOCYANATE METHOD	Trace Scientific , Ltd.	1987-08-21	205
K872511	CHLORIDE FOR CONTINUOUS FLOW INSTRUMENTS	Catachem, Inc.	1987-07-21	27
K870630	CHLORIDE TEST	Sclavo, Inc.	1987-04-22	68
K864713	CHLORIDE REAGENT	Sigma Diagnostics, Inc.	1986-12-31	28
K863585	CHLORIDE PROCEDURE	Data Medical Associates, Inc.	1986-10-16	31
K863620	RAICHEM(TM) CHLORIDE REAGENT	Reagents Applications, Inc.	1986-09-26	10
K863061	CLOROFAST	J. D. Assoc.	1986-09-09	28
K861674	CHLORIDE PROCEDURE	Data Medical Associates, Inc.	1986-07-01	62
K860662	AMRESCO FLOW PAC CHLORIDE REAGENT NO. 2256 & 2271	Amresco, Inc.	1986-03-14	18
K852169	CHLORIDE REAGENT	Pointe Scientific, Inc.,	1985-08-21	93
K852058	CHLORIDE ASSAY KIT	Diagnostic Chemicals, Ltd. (Usa)	1985-07-12	64
K850935	CHLORIDE	Dilab, Inc.	1985-06-10	95
K850334	ROCHE REAGENT FOR CHLORIDE, FOR THE COBAS	Roche Diagnostic Systems, Inc.	1985-03-14	45
K843740	SCLAVO CHLORIDE TEST	Sclavo, Inc.	1984-10-05	10
K842011	CHLORIDE TEST KIT	Mallinckrodt Critical Care	1984-06-22	36
K841047	PARAMAX CHLORIDE REAGENT	American Dade	1984-04-19	38
K834333	FLOW-PAC CHLORIDE REAGENT SET	American Research Products Co.	1984-02-21	71
K832438	CHLORIDE REAGENT SET	Amresco, Inc.	1984-01-20	179
K833746	TECH. RA-1000 SYS SERUM CHLORIDE	Technicon Instruments Corp.	1984-01-13	79
K833166	PROCEDURE 460 FOR DETERM. OF CHLORIDE	Sigma Chemical Co.	1983-10-28	42
K820235	TPTZ CHLORIDE	American Monitor Corp.	1982-02-12	15
K803013	CHLORIDE/TCO2 ANALYZER REAGENTS	Laboratory Products, Inc.	1981-01-02	35
K802163	CHLORIDE COLOR & CHLORIDE SAMPLE DILUENT	Panmed, Inc.	1980-10-10	32
K800683	REAGENT FOR DETERM. CHLORIDE IN HUMAN/SM	Diagnostic Solutions, Inc.	1980-05-28	63
K792605	CHLORIDE REAGENT	Gilford Diagnostics	1980-01-16	29
K792531	SANDARE CHLORIDE PROCEDURE	Sandare Chemical Co., Inc.	1980-01-11	35
K792400	ELVI CHLORIDE	Volu Sol Medical Industries	1979-12-07	11
K781460	CHLORIDE REAGENT	Analytical & Research Chemicals, Inc.	1978-10-10	50

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda