FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS
K Number: K113020
·
Decision Oct 25, 2012
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
93
Applicant Total
55
Review Days
380
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Basic Information
- Device Name
- IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS
- K Number
- K113020
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5660
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Immco Diagnostics, Inc.
- Date Received
- October 11, 2011
- Decision Date
- October 25, 2012
- Product Code
- MID
- 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 |
|---|---|---|---|
| MID | System, Test, Anticardiolipin Immunological | FDA class 2 | Immunology |
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Other Clearances by Immco Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K172745 | ImmuGlo HEp-2 Elite IFA | Jun 5, 2018 | Substantially Equivalent |
| K172078 | ImmuLisa Enhanced RNA POL III Antibody ELISA | Mar 30, 2018 | Substantially Equivalent |
| K163133 | ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA | Aug 8, 2017 | Substantially Equivalent |
| K163177 | ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA | Jul 28, 2017 | Substantially Equivalent |
| K162788 | ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA | Jun 19, 2017 | Substantially Equivalent |
| K151559 | ImmuLisa Enhanced Centromere Antibody ELISA | Mar 11, 2016 | Substantially Equivalent |
| K143736 | ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA | Sep 23, 2015 | Substantially Equivalent |
| K142781 | ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA | Mar 31, 2015 | Substantially Equivalent |
| K123713 | IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA | Oct 25, 2013 | Substantially Equivalent |
| K113143 | IMMULISA SCI-70 ANTIBODY ELISA | Dec 2, 2011 | Substantially Equivalent |