FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE APTUS (AUTOMATED APPLICATION OF THE TPO IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
K Number: K000880
·
Decision May 22, 2000
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
111
Applicant Total
131
Review Days
63
Basic Information
- Device Name
- THE APTUS (AUTOMATED APPLICATION OF THE TPO IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
- K Number
- K000880
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ZEUS SCIENTIFIC, INC.
- Date Received
- March 20, 2000
- Decision Date
- May 22, 2000
- 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 | ||
|---|---|---|---|
| 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 |
| K100728 | ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM | Jul 6, 2010 | Substantially Equivalent |
| K072178 | ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM | May 30, 2008 | Substantially Equivalent |
| K071219 | ATHENA MULTI-LYTE GBM TEST SYSTEM | Dec 6, 2007 | Substantially Equivalent |
| K070317 | ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM | Jul 5, 2007 | Substantially Equivalent |