Euroimmun Euroline Ena Profile 9AG (Igg)
FDA 510(k) K140224 · Euroimmun US
510(k) numberK140224
Submission
- Device name
- Euroimmun Euroline Ena Profile 9AG (Igg)
- Applicant
- Euroimmun US
Morris Plains, NJ, US - Received
- January 29, 2014
- Decision date
- December 9, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LKO – Anti-Rnp Antibody, Antigen And Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
Other 510(k)s with product code LKO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K191085 | Maverick RNP Assay and Maverick Diagnostic SystemLKO · Traditional | Genalyte, Inc. | 10/25/2019SE |
| K123261 | Euroimmun Anti-Nrnp/Sm Elisa (Igg)LKO · Traditional | Euroimmun US | 06/12/2013SE |
| K083117 | Elia RNP70 Immunoassay, Elia SCI-70 Immunoassay and Elia JO-1 Immunoassay, Models…LKO · Traditional | Phadia US, Inc. | 05/28/2009SE |
| K071210 | Modification to Fidis Connective 10*, Model MX006LKO · Traditional | Biomedical Diagnostics (Bmd) SA | 12/19/2007SE |
| K022017 | Rhigene MESACUP-2 Test RNP, Model M7741LKO · Traditional | Rhigene, Inc. | 08/14/2002SE |
| K000752 | Rhigene MESACUP2 Test- RNPLKO · Traditional | Rhigene, Inc. | 05/09/2000SE |
| K993589 | Varelisa RNP AntibodiesLKO · Traditional | Pharmacia & Upjohn Co. | 11/26/1999SE |
| K990624 | Autostat II Anti-Sm/Rnp ElisaLKO · Traditional | Cogent Diagnotics , Ltd. | 04/28/1999SE |
| K984476 | Liquichek Anti-Rnp Control, Eia, Model 207LKO · Traditional | Bio-Rad | 12/22/1998SE |
| K983465 | The Aptus (Automated) Application of the Sm/Rnp Elisa Test System. an Enzyme Linked…LKO · Traditional | Zeus Scientific, Inc. | 11/18/1998SE |
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|---|---|---|
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| K172582 | EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic…MOB · Traditional | 05/24/2018SE |
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| K172244 | EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPatternKTL · Traditional | 04/20/2018SE |
| K172722 | Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)LSR · Traditional | 12/10/2017SE |
| K161513 | Anti-Borrelia burgdorferi US Westernblot (IgG)LSR · Traditional | 08/25/2016SE |
| K153308 | EUROIMMUN Anti-West Nile Virus ELISA (IgM)NOP · Traditional | 08/12/2016SE |
| K153303 | EUROIMMUN Anti-West Nile Virus ELISA (IgG)NOP · Traditional | 08/10/2016SE |
| K142038 | EUROIMMUN LYME ELISA(IgG/IgM)LSR · Traditional | 05/04/2015SE |
Questions and answers
When was Euroimmun Euroline Ena Profile 9AG (Igg) cleared by the FDA?
Euroimmun Euroline Ena Profile 9AG (Igg) (K140224) received a 510(k) decision of Substantially Equivalent on December 9, 2014, 314 days after the submission was received.
What is the product code of K140224?
The FDA product code is LKO – Anti-Rnp Antibody, Antigen And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.