Modification to Fidis Connective 10*, Model MX006
FDA 510(k) K071210 · Biomedical Diagnostics (Bmd) SA
510(k) numberK071210
Submission
- Device name
- Modification to Fidis Connective 10*, Model MX006
- Applicant
- Biomedical Diagnostics (Bmd) SA
Marne La Vallee Cedex 2, FR - Received
- May 1, 2007
- Decision date
- December 19, 2007
- 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 |
| K083117 | Elia RNP70 Immunoassay, Elia SCI-70 Immunoassay and Elia JO-1 Immunoassay, Models…LKO · Traditional | Phadia US, Inc. | 05/28/2009SE |
| 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 |
|---|---|---|
| K102607 | Fidistm Connective 10, Fidistm Analyzer, CarisLLL · Traditional | 12/03/2010SE |
| K100917 | Fidis Vasculitis Assay Kit and Analyzer and Caris SystemMOB · Special | 11/03/2010SE |
| K070458 | Modification to Fidis Vasculitis, Model MX007MOB · Traditional | 12/21/2007SE |
| K061794 | Fidis TM Thyro, Model MX002JZO · Traditional | 11/21/2006SE |
| K060380 | Fidis DsdnaLSW · Traditional | 05/02/2006SE |
| K053383 | Fidis CeliacMST · Traditional | 03/29/2006SE |
| K053653 | Fidis Connective 10, Model MX006LLL · Traditional | 03/13/2006SE |
| K053012 | Fidis Vasculitis, Model MX007MOB · Traditional | 03/02/2006SE |
| K050286 | Fidis Connective 8LLL · Traditional | 10/03/2005SE |
Questions and answers
When was Modification to Fidis Connective 10*, Model MX006 cleared by the FDA?
Modification to Fidis Connective 10*, Model MX006 (K071210) received a 510(k) decision of Substantially Equivalent on December 19, 2007, 232 days after the submission was received.
What is the product code of K071210?
The FDA product code is LKO – Anti-Rnp Antibody, Antigen And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.