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

LAR — Predicate Candidate Screening

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

49 daysmedian FDA review time

154 days90th percentile

25clearances measured

K-number	Device	Applicant	Decided	Review days
K060773	ONLINE TDM PROCAINAMIDE	Roche Diagnostics Corp.	2006-08-23	154
K032573	DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD,	Dade Behring, Inc.	2003-10-31	72
K010812	EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229	Syva Co., Dade Behring, Inc.	2001-04-13	25
K971716	PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM	Bayer Corp.	1997-06-27	49
K963306	CEDIA N-ACETYLPROCAINAMIDE ASSAY	Boehringer Mannheim Corp.	1996-10-29	68
K962099	CEDIA PROCAINAMIDE ASSAY	Boehringer Mannheim Corp.	1996-08-27	90
K962463	PROCAINAMIDE ENZYME IMMUNOASSAY	Diagnostic Reagents, Inc.	1996-08-14	50
K955444	ABBOTT AXSM PROCAINAMIDE ASSAY	Abbott Laboratories	1996-04-02	126
K951434	OPUS PROCAINAMIDE	Behring Diagnostics, Inc.	1995-07-03	97
K942847	COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR	Roche Diagnostic Systems, Inc.	1994-12-02	169
K934762	OPUS PROCAINAMIDE TEST SYSTEM	Pb Diagnostic Systems, Inc.	1994-07-20	289
K922914	EMIT 2000 PROCAINAMIDE CALIBRATORS	Syva Co.	1992-08-24	68
K873350	EASY-TEST EMIT PROCAINAMIDE (PROC) #16648	Em Diagnostic Systems, Inc.	1987-09-29	40
K860141	STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNO.	American Dade	1986-02-11	28
K852320	COBAS FP REAGEN FOR PROCAINAMIDE & PRO CALIBRATOR	Roche Diagnostic Systems, Inc.	1985-07-09	39
K851061	EMIT QST PROCAINAMIDE ASSAY	Syva Co.	1985-04-12	28
K834464	TDX PROCAINAMIDE	Abbott Laboratories	1984-02-03	45
K833384	PROCAINAMIDE ANALYTICAL TEST PACK	E.I. Dupont DE Nemours & Co., Inc.	1983-12-27	89
K832718	EMIT CAD PROCAINAMIDE ASSAY	Syva Co.	1983-09-12	31
K831400	AMES TDA PROCAINAMIDE TEST	Miles Laboratories, Inc.	1983-06-02	34
K823128	ADVANCE EMIT CAD PROCAINAMIDE ASSAY	Syva Co.	1982-11-29	35
K811770	EMIT-CAD PROCAINAMIDE ASSAY	Syva Co.	1981-07-10	18
K811034	EMIT-CAD N-ACETYLPROCAINAMIDE ASSAY	Syva Co.	1981-05-01	15
K790403	EMIT QUINIDINE ASSAY	Syva Co.	1979-03-21	23
K781382	EMIT PROCAINAMIDE ASSAY	Syva Co.	1978-10-17	67

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