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

Beckman Instruments, Inc. — Predicate Candidate Screening

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

50 daysmedian FDA review time

139 days90th percentile

281clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K973448	ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANA	Beckman Instruments, Inc.	1998-09-17	371	0
K982250	ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER	Beckman Instruments, Inc.	1998-07-14	18	3
K981403	IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT	Beckman Instruments, Inc.	1998-05-08	21	0
K981354	ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL	Beckman Instruments, Inc.	1998-05-01	17	1
K980173	ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZE	Beckman Instruments, Inc.	1998-03-18	57	1
K974816	ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER	Beckman Instruments, Inc.	1998-02-20	59	0
K974564	IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT	Beckman Instruments, Inc.	1998-02-17	74	0
K974110	IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT	Beckman Instruments, Inc.	1997-12-24	54	0
K974452	VIGIL LIPID CONTROL	Beckman Instruments, Inc.	1997-12-17	22	1
K973932	BECKMAN CALIBRATOR 2 (CAL2)	Beckman Instruments, Inc.	1997-12-15	61	0
K973928	BECKMAN URINE PROTEIN CALIBRATOR (UCAL)	Beckman Instruments, Inc.	1997-12-01	47	0
K974050	SYNCHRON SYSTEMS C-REACTIVE PROTEIN (CRP) REAGENT	Beckman Instruments, Inc.	1997-11-24	31	0
K973696	SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT	Beckman Instruments, Inc.	1997-11-24	59	2
K973813	IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT	Beckman Instruments, Inc.	1997-11-20	44	0
K974075	ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZE	Beckman Instruments, Inc.	1997-11-10	12	0
K973743	ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER	Beckman Instruments, Inc.	1997-10-31	30	2
K973966	ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER	Beckman Instruments, Inc.	1997-10-31	14	2
K973069	SYNCHRON SYSTEMS METHADONE REAGENT	Beckman Instruments, Inc.	1997-09-22	35	0
K971958	SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENT	Beckman Instruments, Inc.	1997-08-20	84	0
K972819	VIGIL TDM CONTROLS	Beckman Instruments, Inc.	1997-08-13	15	0
K971602	ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT	Beckman Instruments, Inc.	1997-06-27	57	0
K971505	SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT	Beckman Instruments, Inc.	1997-06-11	47	0
K964842	IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEME	Beckman Instruments, Inc.	1997-06-11	190	0
K970905	SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT	Beckman Instruments, Inc.	1997-06-04	84	1
K971788	SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX	Beckman Instruments, Inc.	1997-06-03	20	2
K971283	SYNCHRON SYSTEMS CAL 5 PLUS	Beckman Instruments, Inc.	1997-06-03	57	0
K971506	SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALC	Beckman Instruments, Inc.	1997-06-03	39	0
K971333	SYNCHRON SYSTEMS ALKALINE PHOSPHATASE REAGENT, CHOLINESTERAS	Beckman Instruments, Inc.	1997-05-23	43	0
K970919	SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT	Beckman Instruments, Inc.	1997-05-21	70	0
K971203	SYNCHRON SYSTEMS THYROXINE REAGENT	Beckman Instruments, Inc.	1997-05-16	45	0
K964781	IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT	Beckman Instruments, Inc.	1997-05-09	163	0
K971287	SYNCHRON SYSTEMS DRUG CALIBRATION 3 PLUS	Beckman Instruments, Inc.	1997-05-08	31	0
K964695	IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT	Beckman Instruments, Inc.	1997-04-29	158	0
K964762	IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT	Beckman Instruments, Inc.	1997-04-25	149	0
K964766	IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT)	Beckman Instruments, Inc.	1997-04-25	149	0
K970314	SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS	Beckman Instruments, Inc.	1997-04-21	87	0
K965033	IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-MICROGLOBULIN (AI) REA	Beckman Instruments, Inc.	1997-04-21	125	0
K971210	SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS	Beckman Instruments, Inc.	1997-04-17	15	0
K965035	IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT	Beckman Instruments, Inc.	1997-04-17	121	0
K964257	IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG	Beckman Instruments, Inc.	1997-03-24	150	0
K963976	IMMUNOCHEMISTRY SYS URINE TRANSFERRIN REAGENT	Beckman Instruments, Inc.	1997-03-19	166	0
K965240	SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMI	Beckman Instruments, Inc.	1997-03-10	70	12
K965108	SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT	Beckman Instruments, Inc.	1997-03-06	76	2
K963974	IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN	Beckman Instruments, Inc.	1997-03-06	155	0
K964843	IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN FACTOR B (PFB) REAGE	Beckman Instruments, Inc.	1997-03-06	93	0
K964009	IMMAGE IMMUNOCHEMISTRY SYSTEM GENTAMICIN(GEN)/TOBRAMYCIN(TOB	Beckman Instruments, Inc.	1997-02-11	127	0
K964260	IMMAGE IMMUNOCHEMISTRY SYSTEM KAPPA LIGHT CHAIN (KAP) REAGEN	Beckman Instruments, Inc.	1997-02-10	108	0
K964010	IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (AP	Beckman Instruments, Inc.	1997-02-10	126	0
K963868	IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA	Beckman Instruments, Inc.	1997-02-10	137	2
K963673	IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGE	Beckman Instruments, Inc.	1997-02-04	144	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