Total clearances
7
2022-04-29 → 2026-05-08
Name variants in FDA filings: Zeus Scientific / Zeus Scientific, Inc.
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| LLL |
Extractable Antinuclear Antibody, Antigen And Control |
Class II |
Immunology |
2 |
2025-10-22 |
| OBE |
— |
— |
— |
1 |
2026-05-08 |
| MOB |
Test System, Antineutrophil Cytoplasmic Antibodies (Anca) |
Class II |
Immunology |
1 |
2025-05-07 |
| KTL |
Anti-Dna Indirect Immunofluorescent Solid Phase |
Class II |
Immunology |
1 |
2023-08-31 |
| LSR |
— |
— |
— |
1 |
2023-07-13 |
| DHN |
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
Class II |
Immunology |
1 |
2022-04-29 |
Safety
Recalls (2)
Class I (serious)
0
Risk of injury / death
| Date | Severity | Status | Recall # |
Product | Code | Reason |
| 2023-10-31 |
Class II
|
Ongoing |
Z-0603-2024 |
ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G |
— |
The organization completed a product improvement process to the conjugate found within the certain ELISA kits. This modification was not reviewed and approved … |
| 2023-10-31 |
Class II
|
Ongoing |
Z-0602-2024 |
ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M |
— |
The organization completed a product improvement process to the conjugate found within the certain ELISA kits. This modification was not reviewed and approved … |
Filings
All 510(k) clearances (7)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2026-05-08 |
K250814 |
Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB |
OBE |
— |
— |
| 2025-10-22 |
K250666 |
Alegria Flash CTD Screen |
LLL |
Class II |
Immunology |
| 2025-09-19 |
K250408 |
Alegria Flash ENA Screen |
LLL |
Class II |
Immunology |
| 2025-05-07 |
K243776 |
Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) |
MOB |
Class II |
Immunology |
| 2023-08-31 |
K231616 |
ZEUS IFA(TM) nDNA Test System, ZEUS dIFine |
KTL |
Class II |
Immunology |
| 2023-07-13 |
K230863 |
ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit |
LSR |
— |
— |
| 2022-04-29 |
K201956 |
Zeus IFA ANA HEp-2 Test System, Zeus dIFine |
DHN |
Class II |
Immunology |