FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENA PROFILE-6 ELISA TEST SYSTEM
K Number: K941409
·
Decision Jun 10, 1994
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
111
Applicant Total
135
Review Days
79
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
- ENA PROFILE-6 ELISA TEST SYSTEM
- K Number
- K941409
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Zeus Scientific, Inc.
- Date Received
- March 23, 1994
- Decision Date
- June 10, 1994
- Product Code
- LJM
- 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 |
|---|---|---|---|
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LJM), ordered by most recent decision date.
EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay
FDA 510(k)
FDA Class 2
·Immunology
ImmuLisa Enhanced Centromere Antibody ELISA
FDA 510(k)
FDA Class 2
·Immunology
ELIA SCL-70S IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Immunology
QUANTA FLASH CENTROMERE
FDA 510(k)
FDA Class 2
·Immunology
GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT
FDA 510(k)
FDA Class 2
·Immunology
ANA SCREEN ELISA (IGG)
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 |