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

Beckman-Diagnostic Systems Group — Predicate Candidate Screening

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

79 daysmedian FDA review time

249 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K945522	I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS	Beckman-Diagnostic Systems Group	1994-12-12	32
K944605	CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEM	Beckman-Diagnostic Systems Group	1994-12-07	79
K944604	CX AMPHETAMINES REAGENT FOR SYNCHRON CX SYSTEMS	Beckman-Diagnostic Systems Group	1994-12-07	79
K944606	CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS	Beckman-Diagnostic Systems Group	1994-11-30	72
K942676	SYNCHRON CX3 DELTA	Beckman-Diagnostic Systems Group	1994-11-02	149
K934293	BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT	Beckman-Diagnostic Systems Group	1994-07-06	307
K934068	BECKMAN DIRECT BILIRUBIN REAGENT	Beckman-Diagnostic Systems Group	1994-04-26	249
K936184	VIGIL PRX CHEMISTRY CONTROL	Beckman-Diagnostic Systems Group	1994-04-15	109
K934271	BECKMAN SYNCHRON LACTATE REAGENT	Beckman-Diagnostic Systems Group	1993-11-09	70
K934046	BECKMAN CHOLESTEROL REAGENT	Beckman-Diagnostic Systems Group	1993-10-28	70
K934467	BECKMAN CX AMMONIA/ALCOHOL CONTROL	Beckman-Diagnostic Systems Group	1993-10-27	47

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