FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE APTUS (AUTOMATED) APPLICATION OF THE ANCA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
K Number: K984034
·
Decision Nov 30, 1998
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
73
Applicant Total
135
Review Days
18
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- THE APTUS (AUTOMATED) APPLICATION OF THE ANCA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
- K Number
- K984034
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5660
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Zeus Scientific, Inc.
- Date Received
- November 12, 1998
- Decision Date
- November 30, 1998
- Product Code
- MOB
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MOB), ordered by most recent decision date.
Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)
FDA 510(k)
FDA Class 2
·Immunology
EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic EUROPattern
FDA 510(k)
FDA Class 2
·Immunology
AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin
FDA 510(k)
FDA Class 2
·Immunology
EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay
FDA 510(k)
FDA Class 2
·Immunology
NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit
FDA 510(k)
FDA Class 2
·Immunology
ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Zeus Scientific, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K201956 | Zeus IFA ANA HEp-2 Test System, Zeus dIFine | Apr 29, 2022 | Substantially Equivalent |
| K190907 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System | Jul 29, 2019 | Substantially Equivalent |
| K191240 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System | Jul 29, 2019 | Substantially Equivalent |
| K191398 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System | Jul 29, 2019 | Substantially Equivalent |
| K113397 | ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM | Jul 26, 2012 | Substantially Equivalent |
| K102425 | ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM | Dec 12, 2011 | Substantially Equivalent |
| K103603 | ZEUS ELISA HSV GG-2 IGG TEST SYSTEM | May 20, 2011 | Substantially Equivalent |
| K103363 | ZEUS ELISA HSV GC-I IGG TEST SYSTEM | Apr 26, 2011 | Substantially Equivalent |
| K102283 | ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM | Feb 10, 2011 | Substantially Equivalent |
| K093784 | ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM | Jul 16, 2010 | Substantially Equivalent |