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

Abbott Laboratories — Predicate Candidate Screening

883 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

61 daysmedian FDA review time

242 days90th percentile

883clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K252424	Anti-HCV Next	Abbott Laboratories	2026-04-28	270	0
K243500	ARCHITECT iGentamicin	Abbott Laboratories	2025-07-09	239	0
K243168	Alinity i Rubella IgG	Abbott Laboratories	2025-06-20	263	0
K243283	Alinity h-series System	Abbott Laboratories	2025-02-20	126	1
K233932	Alinity i Toxo IgM	Abbott Laboratories	2024-08-30	260	0
K232669	TBI	Abbott Laboratories	2023-09-29	28	0
K222850	HAVAb IgG II	Abbott Laboratories	2023-08-10	323	0
K220031	Alinity h-series System	Abbott Laboratories	2023-08-04	576	2
K220282	i-STAT PTplus Cartridge with the i-STAT 1 System	Abbott Laboratories	2023-07-14	528	0
K230937	Alinity i Total ß-hCG Reagent Kit, GLP systems Track	Abbott Laboratories	2023-06-05	63	0
K230790	Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent	Abbott Laboratories	2023-05-19	58	0
K223602	Traumatic brain injury (TBI) test	Abbott Laboratories	2023-03-02	90	0
K220949	Architect CMV IgG	Abbott Laboratories	2022-10-27	209	0
K210596	ARCHITECT Toxo IgG	Abbott Laboratories	2022-05-19	444	0
K213486	GLP systems Track	Abbott Laboratories	2022-03-10	132	0
K201778	i-STAT TBI Plasma cartridge with the i-STAT Alinity System	Abbott Laboratories	2021-01-08	192	0
K190294	CELL-DYN Emerald 22 AL System	Abbott Laboratories	2019-03-15	32	0
K181748	Magnesium	Abbott Laboratories	2018-09-12	72	0
K173294	Magnesium	Abbott Laboratories	2018-05-18	214	0
K173122	Abbott Architect Free T4	Abbott Laboratories	2017-10-27	28	0
K170320	Alinity c ICT Sample Diluent	Abbott Laboratories	2017-10-24	265	0
K170317	Alinity i Total ß-hCG Reagent Kit, Alinity i System	Abbott Laboratories	2017-10-23	264	2
K170316	ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM	Abbott Laboratories	2017-10-19	260	1
K163342	i-STAT Hematocrit test with i-STAT Alinity System	Abbott Laboratories	2017-08-22	266	0
K170160	Abbott ARCHITECT Free T3	Abbott Laboratories	2017-02-15	28	0
K153375	ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P	Abbott Laboratories	2016-08-12	263	0
K153730	ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibra	Abbott Laboratories	2016-06-15	170	0
K152155	ARCHITECT 2nd Generation Testosterone	Abbott Laboratories	2015-12-17	136	0
K152442	Freestyle Freedom Blood Glucose Monitoring Sytem	Abbott Laboratories	2015-12-17	112	0
K151566	Abbott ARCHITECT Total T4 Calibrators	Abbott Laboratories	2015-07-10	30	0
K150332	FreeStyle Lite Blood Glucose Monitoring System	Abbott Laboratories	2015-06-05	115	0
K150531	FreeStyle Freedom Lite Blood Glucose Monitoring System	Abbott Laboratories	2015-06-05	95	0
K140654	Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin	Abbott Laboratories	2015-05-22	434	0
K150510	Total Bilirubin	Abbott Laboratories	2015-04-02	34	0
K130255	HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C C	Abbott Laboratories	2014-02-28	392	1
K123089	FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT2423	Abbott Laboratories	2013-04-05	186	0
K121985	ARCHITECT TOTAL BILIRUBIN	Abbott Laboratories	2013-02-01	210	0
K123372	ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR	Abbott Laboratories	2013-01-14	74	0
K121003	ABBOTT PLEX-ID FLU ASSAY	Abbott Laboratories	2012-12-21	263	0
K123379	ABBOTT ARCHITECT FREE T4	Abbott Laboratories	2012-11-27	26	0
K120009	TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MA	Abbott Laboratories	2012-09-11	252	0
K113704	ARCHITECT HAVAB-G	Abbott Laboratories	2012-06-28	195	1
K121314	ARCHITECT B12	Abbott Laboratories	2012-05-17	15	0
K113719	SAFETY SCREW CONNECTOR	Abbott Laboratories	2012-04-20	123	0
K111874	FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS	Abbott Laboratories	2012-02-16	230	0
K110381	CELL-DYN EMERALD 22 SYSTEM	Abbott Laboratories	2011-12-22	315	0
K103627	ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT	Abbott Laboratories	2011-10-14	305	0
K110579	ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHI	Abbott Laboratories	2011-10-06	219	0
K111023	ABBOTT ARCHITECT LH CALIBRATORS	Abbott Laboratories	2011-06-10	58	0
K102568	URIC ACID MODEL 3P39	Abbott Laboratories	2011-05-06	241	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