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

LQN — Predicate Candidate Screening

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

182 daysmedian FDA review time

300 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K031490	RUBELLACOL	Immunostics Inc.,	2003-07-16	65
K970931	COPALIS TORC TOTAL ANTIBODY ASSAY	Sienna Biotech, Inc.	1997-04-24	48
K961784	COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV	Sienna Biotech, Inc.	1996-10-31	182
K954920	MUREX RUB-EX	Murex Diagnostics, Inc.	1996-08-21	300
K952544	COLORSLIDER RUBELLA	Seradyn, Inc.	1996-01-17	229
K912391	RUBALEX, MODIFICATION	Orion Corp.	1992-05-04	346
K901637	RESUBMITTED MODIFIED RUBALEX	Orion Corp.	1990-04-26	17
K896433	MODIFIED RUBAGEN	Biokit USA, Inc.	1989-11-29	20
K893755	RUBAGEN	Biokit USA, Inc.	1989-08-21	94
K861881	RUBALEX (REVISED VERSION)	Orion Corp.	1986-06-04	27
K852788	RUBALEX	Orion Corp.	1986-03-12	254
K844436	VIROGEN RUBELLA MICROTITER TEST	Armkel, LLC	1985-05-21	186
K844435	VIROGEN RUBELLA SLIDE TEST	Armkel, LLC	1985-05-20	185

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