Orgentec Anti-Rnp/Sm Pin Immuno Assay
FDA 510(k) K954831 · Orgentec
510(k) numberK954831
Submission
- Device name
- Orgentec Anti-Rnp/Sm Pin Immuno Assay
- Applicant
- Orgentec
Windham, NH, US - Received
- October 20, 1995
- Decision date
- May 8, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
|---|---|---|
| K954830 | Orgentec Anti-Sm(Smith) Pin Immuno AssayLKP · Traditional | 05/08/1996SE |
| K954832 | Orgentec Anti-Ss-B(La) Pin Immuno AssayLJM · Traditional | 04/18/1996SE |
| K954829 | Orgentec ANTI-JO-1 Pin Immuno AssayLJM · Traditional | 04/18/1996SE |
| K954815 | Orgentec Anti-Ss-A(Ro) Pin Immuno AssayLJM · Traditional | 04/18/1996SE |
| K954814 | Orgentec Anti-Scl 70 Pin Immuno AssayLJM · Traditional | 04/18/1996SE |
| K960274 | Orgentec Micro-Albumin Pin Eia AssayJIR · Traditional | 03/29/1996SE |
| K955134 | Orgentec Enascreen Elisa AssayLLL · Traditional | 03/20/1996SE |
| K955133 | Orgentec Enascreen Pin Immuno AssayLLL · Traditional | 03/20/1996SE |
| K953671 | Orgen Tec Anti-Dsdna Elisa AssayLRM · Traditional | 11/09/1995SE |
Questions and answers
When was Orgentec Anti-Rnp/Sm Pin Immuno Assay cleared by the FDA?
Orgentec Anti-Rnp/Sm Pin Immuno Assay (K954831) received a 510(k) decision of Substantially Equivalent on May 8, 1996, 201 days after the submission was received.
What is the product code of K954831?
The FDA product code is LKO – Anti-Rnp Antibody, Antigen And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.