Anti-Rnp and Anti-Sm Antibody Test
FDA 510(k) K895338 · Immco Diagnostics, Inc.
510(k) numberK895338
Submission
- Device name
- Anti-Rnp and Anti-Sm Antibody Test
- Applicant
- Immco Diagnostics, Inc.
Buffalo, NY, US - Received
- August 31, 1989
- Decision date
- October 17, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
More from Bio-Rad
| 510(k) | Device | Decision |
|---|---|---|
| K172745 | ImmuGlo HEp-2 Elite IFADHN · Traditional | 06/05/2018SE |
| K172078 | ImmuLisa Enhanced RNA POL III Antibody ELISANYO · Traditional | 03/30/2018SE |
| K163133 | ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISADBM · Traditional | 08/08/2017SE |
| K163177 | ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISAMST · Traditional | 07/28/2017SE |
| K162788 | ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA…MSV · Traditional | 06/19/2017SE |
| K151559 | ImmuLisa Enhanced Centromere Antibody ELISALJM · Traditional | 03/11/2016SE |
| K143736 | ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA…DHR · Traditional | 09/23/2015SE |
| K142781 | ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA…LLL · Traditional | 03/31/2015SE |
| K123713 | Immulisa Enhanced Celiac Fusion (Ttg/Dgp) Iga/Igg Antibody ElisaMVM · Traditional | 10/25/2013SE |
| K113020 | Immulisa Enhanced (TM) Cardiolipin Iga, Igg, Igm and Iga/Igg/Igm Antibody (Aca) ElisasMID · Traditional | 10/25/2012SE |
Questions and answers
When was Anti-Rnp and Anti-Sm Antibody Test cleared by the FDA?
Anti-Rnp and Anti-Sm Antibody Test (K895338) received a 510(k) decision of Substantially Equivalent on October 17, 1989, 47 days after the submission was received.
What is the product code of K895338?
The FDA product code is LKO – Anti-Rnp Antibody, Antigen And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.