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

CGZ — Predicate Candidate Screening

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

61 daysmedian FDA review time

265 days90th percentile

38clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K182072	VITROS Chemistry Products Cl-Slides, VITROS Chemistry Produc	Ortho-Clinical Diagnostics, Inc.	2018-10-30	90	1
K170320	Alinity c ICT Sample Diluent	Abbott Laboratories	2017-10-24	265	0
K162020	VITROS Chemistry Products Cl- Slides	Ortho Clinical Diagnostics	2016-12-16	148	0
K082099	VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRO	Ortho-Clinical Diagnostics, Inc.	2008-08-21	27	0
K070889	AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112	Wallac OY	2008-04-14	381	0
K070531	ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLIN	Thermo Fisher Scientific	2007-09-04	193	0
K060108	COBAS INTEGRA CHLORIDE ELCTRODE GEN.2	Roche Diagnostics Corp.	2006-02-16	34	0
K052027	OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200	Osmetech, Inc.	2005-09-29	64	4
K020148	pHoenix ISE Reagents FOR Olympus AU Chemistry Systems	Phoenix Diagnostics, Inc.	2002-02-04	19	0
K013451	PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERI	Phoenix Diagnostics, Inc.	2001-12-18	61	0
K003664	DELFIA NEONATAL IRT KIT, MODEL A005-110	Wallac OY	2001-02-14	78	0
K003668	AUTODELFIA NEONATAL IRT KIT, MODEL B005-112	Wallac OY	2001-02-12	76	0
K993697	DELFIA NEONATAL IRT KIT	Wallac OY	2000-06-09	220	0
K000926	EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER	Medica Corp.	2000-05-15	54	0
K991870	ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 11	A.P. Total Care, Inc.	1999-07-30	59	0
K981270	IRMA BLOOD ANALYSIS SYSTEM	Diametrics Medical, Inc.	1998-05-01	24	0
K980757	ILAB 600 CLINICAL CHEMISTRY SYSTEM	Instrumentation Laboratory CO	1998-04-21	53	0
K980367	AEROSET SYSTEM	Abbott Laboratories	1998-04-01	62	25
K973742	SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM	Sendx Medical, Inc.	1997-12-03	63	0
K972004	ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS	Alko Diagnostic Corp.	1997-06-16	17	0
K962479	SYNERMED ISE REAGENTS	Synermed, Inc.	1997-03-03	250	0
K963992	CAPILLARY ADAPTOR ACCESSORY	Medica Corp.	1996-11-29	56	0
K963734	ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMIST	Alko Diagnostic Corp.	1996-10-24	56	0
K953860	HICHEM ISE DILUENT KIT 70008	Hichem Diagnostics	1995-09-06	20	0
K953861	HICHEM ISE INTDERNAL REFERENCE KIT 70009	Hichem Diagnostics	1995-09-06	20	0
K953862	HICHEM ISEKCI SOLUTION KIT 70010	Hichem Diagnostics	1995-09-06	20	0
K935228	MODEL 644 SWEAT DILUENT	Ciba Corning Diagnostics Corp.	1994-08-01	273	0
K924864	NOVA 13 ANALYZER, MODIFICATION	Nova Biomedical Corp.	1992-11-06	56	0
K912561	NOVA 13 ANALYZER	Nova Biomedical Corp.	1991-09-11	92	0
K912647	ISE/CI-	Boehringer Mannheim Corp.	1991-07-17	30	0
K900887	ABBOTT SPECTRUM AUTOMATED CLINICAL CHEM. ANALYZER	Abbott Laboratories	1990-05-15	78	0
K893628	OLYMPUS ISE MODULE FOR AU5000	Olympus Corp.	1989-08-11	92	0
K885193	OLYMPUS ISE MODULE	Olympus Corp.	1989-02-03	49	0
K863395	WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZER	Wescor, Inc.	1988-05-24	629	0
K861669	SODIUM, POTASSIUM AND CHLORIDE PROCEDURE	Data Medical Associates, Inc.	1986-05-27	27	0
K860668	ION-SPECIFIC ELECTRODE, CHLORIDE	Em Diagnostic Systems, Inc.	1986-04-07	42	0
K844021	ISE REAGENTS FOR DEMAND ANALYZER	Advanced Biomedical Methods, Inc.	1984-12-10	56	0
K790653	NOVA 3 CHLORIDE/TOTAL DIOXIDE ANALYZER	Nova Corp.	1979-06-15	71	0

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