Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

Abbott Diagnostics — Predicate Candidate Screening

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

53 daysmedian FDA review time

173 days90th percentile

28clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K964185	IMX CA 125	Abbott Diagnostics	1997-11-04	379	4
K972182	ABBOTT STREP A CONTROLS	Abbott Diagnostics	1997-08-13	76	0
K961439	ABBOTT CELL-DYN 4000 SYSTEM	Abbott Diagnostics	1996-10-18	186	7
K890491	CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER	Abbott Diagnostics	1989-04-18	77	1
K881242	CELL-DYN RAPID-LYSE AND HEMOGLOBLIN	Abbott Diagnostics	1988-04-21	36	0
K881130	CELL-DYN ISOTONIC DILUENT	Abbott Diagnostics	1988-03-31	15	0
K873348	CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.	Abbott Diagnostics	1987-09-09	20	0
K873347	CELL-DYN DIFF. SCREEN ISOTONIC DILUENT	Abbott Diagnostics	1987-09-09	20	0
K873408	MODEL 690 SPECTROPHOTOMETER	Abbott Diagnostics	1987-09-08	14	0
K872761	CELL-DYN 610 HEMATOLOGY ANALYZER	Abbott Diagnostics	1987-08-06	24	0
K870233	CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER	Abbott Diagnostics	1987-03-17	55	5
K854368	CELL-DYN 1500 MULTI-PARAMETER HEMATOLOGY ANALYZER	Abbott Diagnostics	1986-01-01	64	0
K852371	CELL-DYN 2000 AUTOMATED MULTI-PARAMETER HEMATOLOGY	Abbott Diagnostics	1985-09-17	105	0
K852372	CELL-DYN BRAND HEMATOLOGY REAGENTS	Abbott Diagnostics	1985-09-03	91	0
K852373	AD150, AUTOMATED HEMATOLOGY DILUTOR	Abbott Diagnostics	1985-07-05	31	0
K845019	CELL-DYN 1000 AUTOMATED HEMATOLOGY ANALYZER	Abbott Diagnostics	1985-03-26	89	0
K842786	DYNA-LYTE 2000	Abbott Diagnostics	1984-09-14	115	0
K842446	DILU-MATIC 140	Abbott Diagnostics	1984-09-06	77	0
K840170	CELL-DYN 100 WHOLE BLOOD PLATELET	Abbott Diagnostics	1984-03-02	43	0
K832643	CELL-DYN 900 HEMATOLOGY ANALYZER	Abbott Diagnostics	1983-09-26	53	0
K832206	SPECTROPHOTOMETER #390	Abbott Diagnostics	1983-08-24	48	0
K831368	CELL-DYN 400 HEMOTOLOGY ANALYZER	Abbott Diagnostics	1983-07-18	83	0
K832038	CELL-DYN 300 HEMATOLOGY ANALYZER	Abbott Diagnostics	1983-07-18	24	0
K830624	FLUOROMETER, GENERAL USE	Abbott Diagnostics	1983-04-05	36	0
K823344	HEMATOLOGY ANALYZER	Abbott Diagnostics	1982-12-28	50	0
K822720	MODEL 340 SPECTROPHOTOMETER	Abbott Diagnostics	1982-10-08	31	0
K803218	CELL DYN 800 HEMATOLOGY ANALYZER	Abbott Diagnostics	1981-06-09	173	0
K810135	MODEL AM 721 ELECTROLYTE ANALYZER	Abbott Diagnostics	1981-02-10	20	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