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

Zeus Scientific, Inc. — Predicate Candidate Screening

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

81 daysmedian FDA review time

232 days90th percentile

135clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K201956	Zeus IFA ANA HEp-2 Test System, Zeus dIFine	Zeus Scientific, Inc.	2022-04-29	654	0
K190907	ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS E	Zeus Scientific, Inc.	2019-07-29	112	0
K191398	ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS E	Zeus Scientific, Inc.	2019-07-29	66	0
K191240	ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS E	Zeus Scientific, Inc.	2019-07-29	82	0
K113397	ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM	Zeus Scientific, Inc.	2012-07-26	252	0
K102425	ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM	Zeus Scientific, Inc.	2011-12-12	474	0
K103603	ZEUS ELISA HSV GG-2 IGG TEST SYSTEM	Zeus Scientific, Inc.	2011-05-20	163	0
K103363	ZEUS ELISA HSV GC-I IGG TEST SYSTEM	Zeus Scientific, Inc.	2011-04-26	160	0
K102283	ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM	Zeus Scientific, Inc.	2011-02-10	182	0
K093784	ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM	Zeus Scientific, Inc.	2010-07-16	219	0
K100728	ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM	Zeus Scientific, Inc.	2010-07-06	113	0
K072178	ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM	Zeus Scientific, Inc.	2008-05-30	298	0
K071219	ATHENA MULTI-LYTE GBM TEST SYSTEM	Zeus Scientific, Inc.	2007-12-06	218	0
K070317	ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM	Zeus Scientific, Inc.	2007-07-05	153	0
K063186	ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM	Zeus Scientific, Inc.	2007-03-21	152	0
K051484	ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTE	Zeus Scientific, Inc.	2005-12-05	182	0
K042118	ATHENA MULTI-LYTE EBV IGG TEST SYSTEM	Zeus Scientific, Inc.	2005-04-29	266	0
K042092	ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM	Zeus Scientific, Inc.	2005-04-12	252	0
K042416	ATHENA MULTI-LYTE ANA-II TEST SYSTEM	Zeus Scientific, Inc.	2004-10-08	31	0
K040111	ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SY	Zeus Scientific, Inc.	2004-04-05	76	0
K033977	ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYS	Zeus Scientific, Inc.	2004-03-22	90	0
K033802	ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM	Zeus Scientific, Inc.	2004-02-27	81	0
K021103	MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST	Zeus Scientific, Inc.	2002-04-24	19	0
K011244	ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM	Zeus Scientific, Inc.	2001-12-10	231	0
K001393	THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TE	Zeus Scientific, Inc.	2000-06-07	35	0
K000879	THE APTUS (AUTOMATED) APPLICATION OF THE TG IGG ELISA TEST S	Zeus Scientific, Inc.	2000-05-22	63	0
K000880	THE APTUS (AUTOMATED APPLICATION OF THE TPO IGG ELISA TEST S	Zeus Scientific, Inc.	2000-05-22	63	0
K000362	MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SY	Zeus Scientific, Inc.	2000-02-18	14	0
K000363	MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELI	Zeus Scientific, Inc.	2000-02-18	14	0
K993250	THE APTUS (AUTOMATED) APPLICATION OF THE GLIADIN IGG ELISA T	Zeus Scientific, Inc.	1999-11-12	45	0
K992166	THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA T	Zeus Scientific, Inc.	1999-09-03	70	0
K991185	BORRELIA BURGDORFERI IGM WESTERN BLOT TEST SYSTEM	Zeus Scientific, Inc.	1999-09-03	148	0
K991180	BORRELIA BURGDORFERI IGG WESTERN BLOT TEST SYSTEM	Zeus Scientific, Inc.	1999-09-03	148	0
K991820	HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED	Zeus Scientific, Inc.	1999-08-12	77	0
K984180	THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA T	Zeus Scientific, Inc.	1999-07-20	239	1
K991610	ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM.	Zeus Scientific, Inc.	1999-06-25	46	0
K991179	ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM	Zeus Scientific, Inc.	1999-06-17	71	0
K983805	THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGG ELISA T	Zeus Scientific, Inc.	1999-05-26	210	0
K984120	THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST	Zeus Scientific, Inc.	1999-05-26	189	0
K984135	THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TES	Zeus Scientific, Inc.	1999-05-26	189	0
K990204	GLIADIN IGG ELISA TEST SYSTEM	Zeus Scientific, Inc.	1999-03-26	64	0
K990207	GLIADIN IGA ELISA TEST SYSTEM	Zeus Scientific, Inc.	1999-03-26	64	0
K984138	APTUS (AUTOMATED) APPLICATION FOR THE B. BURGDORFERI ANTIBOD	Zeus Scientific, Inc.	1999-03-23	125	0
K983656	HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM	Zeus Scientific, Inc.	1999-03-18	150	0
K984317	THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGG ELIS	Zeus Scientific, Inc.	1999-01-22	50	0
K984181	THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST	Zeus Scientific, Inc.	1999-01-22	60	0
K984170	THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGM ELIS	Zeus Scientific, Inc.	1999-01-19	60	0
K984139	THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGG ELISA TEST	Zeus Scientific, Inc.	1999-01-11	54	0
K984133	THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST	Zeus Scientific, Inc.	1999-01-11	54	0
K984126	THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGG ELISA T	Zeus Scientific, Inc.	1999-01-11	54	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