Elia RNP70 Immunoassay, Elia SCI-70 Immunoassay and Elia JO-1 Immunoassay, Models 14-5511-01, 14-5506-01 and 14-5507-01
FDA 510(k) K083117 · Phadia US, Inc.
510(k) numberK083117
Submission
- Device name
- Elia RNP70 Immunoassay, Elia SCI-70 Immunoassay and Elia JO-1 Immunoassay, Models 14-5511-01, 14-5506-01 and 14-5507-01
- Applicant
- Phadia US, Inc.
Portage, MI, US - Received
- October 22, 2008
- Decision date
- May 28, 2009
- 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 |
| K140224 | Euroimmun Euroline Ena Profile 9AG (Igg)LKO · Traditional | Euroimmun US | 12/09/2014SE |
| K123261 | Euroimmun Anti-Nrnp/Sm Elisa (Igg)LKO · Traditional | Euroimmun US | 06/12/2013SE |
| 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 |
More from Zeus Scientific, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K141375 | Elia M2; Immunoassay, Positive Control 100, Positive Control 250DBM · Traditional | 02/13/2015SE |
| K140225 | Elia PR3S Immunoassay, Elia Mpos Immunoassay, Elia GBM Immunoassay, Elia Anca/Gbm…MOB · Traditional | 10/27/2014SE |
| K132631 | Eia SMDP ImmunoassayLKP · Traditional | 08/29/2014SE |
| K131821 | Elia(Tm) Cardiolipin Iga ImmunoassayMID · Traditional | 12/23/2013SE |
| K122197 | Automated in Vitro Quantitative Assay for the Measurement of Allergen Specific Ige…DHB · Traditional | 08/28/2013SE |
| K113841 | Immunocap Allergen Components BundleDHB · Traditional | 09/13/2012SE |
| K112414 | Elia B2-GLYCOPROTEIN I Iga ImmunoassayMSV · Traditional | 06/22/2012SE |
| K111919 | Immunocap Specific Ige Allergen Bundle, 12 Allergen ComponentsDHB · Traditional | 12/22/2011SE |
| K102673 | Rheumatoid Factor Immunological Test SystemDHR · Traditional | 09/30/2011SE |
| K093459 | Elia Gliadin DP Iga Immunoassay and Elia Gliadin DP Igg Immunoassay, Models 14-5538-01…MST · Traditional | 08/13/2010SE |
Questions and answers
When was Elia RNP70 Immunoassay, Elia SCI-70 Immunoassay and Elia JO-1 Immunoassay, Models 14-5511-01, 14-5506-01 and 14-5507-01 cleared by the FDA?
Elia RNP70 Immunoassay, Elia SCI-70 Immunoassay and Elia JO-1 Immunoassay, Models 14-5511-01, 14-5506-01 and 14-5507-01 (K083117) received a 510(k) decision of Substantially Equivalent on May 28, 2009, 218 days after the submission was received.
What is the product code of K083117?
The FDA product code is LKO – Anti-Rnp Antibody, Antigen And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.