# Zeus Scientific, Inc.

- Location (FDA's records): Branchburg, NJ
- FDA decisions: 145 (1976–2026): 142 510(k) clearances and 3 original PMA approvals
- Names in FDA's records: Zeus Scientific, Inc. (138); Zeus Scientific (7)
- Product codes: LSR (13), MID (9), MOB (9), LLL (9), LJM (6), DHN (6), LFX (5), LSE (5), GQL (5), LFZ (5), LFY (4), MST (4)
- 510(k) review time since 2016: median 82 days, against 86 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 7 (5 its own); citations of its devices by later devices: 15 (5 its own)
- Recalls linked to its devices: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Mrl Diagnostics: 2 (https://510kreport.com/company/mrl-diagnostics)

## Firms that cite its devices most
- DiaSorin, Inc.: 5 (https://510kreport.com/company/diasorin)
- Roche Diagnostics Corp.: 3 (https://510kreport.com/company/roche-diagnostics)
- Bio-Rad Laboratories, Inc.: 1 (https://510kreport.com/company/bio-rad-laboratories)
- Diagnostic Products Corp.: 1 (https://510kreport.com/company/diagnostic-products)

## Its most-cited devices
- K984180: The Aptus (Automated) Application of the Rubella Igm Elisa Test System (1999), cited by 2
- K071219: Athena Multi-Lyte GBM Test System (2007), cited by 1
- K113397: Zeus Elisa Borrelia Vlse-1/PEPC10 Igg/Igm Test System (2012), cited by 1
- K191240: ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System (2019), cited by 1
- K891783: Rubella Elisa Test System (1989), cited by 1
- K011244: Zeus Scientific, Inc. Athena Multi-Lyte Ana Test System (2001), cited by 1

## Recent decisions
- K261466: Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM (Aug 21, 2026)
- K250814: Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB (May 8, 2026)
- K250666: Alegria Flash CTD Screen (Oct 22, 2025)
- K250408: Alegria Flash ENA Screen (Sep 19, 2025)
- K243776: Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) (May 7, 2025)
- K231616: ZEUS IFA (TM) nDNA Test System, ZEUS dIFine (Aug 31, 2023)
- K230863: ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit (Jul 13, 2023)
- K201956: Zeus IFA ANA HEp-2 Test System, Zeus dIFine (Apr 29, 2022)

Source page: https://510kreport.com/company/zeus-scientific