Rhigene MESACUP2 Test- RNP
FDA 510(k) K000752 · Rhigene, Inc.
510(k) numberK000752
Submission
- Device name
- Rhigene MESACUP2 Test- RNP
- Applicant
- Rhigene, Inc.
Des Plaines, IL, US - Received
- March 8, 2000
- Decision date
- May 9, 2000
- 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 |
| 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 |
|---|---|---|
| K040711 | Mesacup Test PR-3MOB · Traditional | 04/02/2004SE |
| K040586 | Mesacup Test Mpo, Model 11053MOB · Traditional | 03/22/2004SE |
| K040200 | MESACUP-2 Test Cenp-BLJM · Traditional | 03/04/2004SE |
| K033528 | MESACUP-2 Test JO-1, Model 10756LLL · Traditional | 12/22/2003SE |
| K031308 | Rhigene MESACUP-2 Anti-Mitochondria M2 Test, Model 10760DBM · Traditional | 09/26/2003SE |
| K022017 | Rhigene MESACUP-2 Test RNP, Model M7741LKO · Traditional | 08/14/2002SE |
| K022018 | Rhigene Ana Elisa Test System, Model K7560LJM · Special | 07/05/2002SE |
| K011068 | Rhigene Ndna Test System for Imagetiter, Model CL100LKTL · Traditional | 04/11/2002SE |
| K000336 | Rhigene DSG-1 & DSG-3 Elisa Test System, Model 7680 ENBO · Traditional | 06/09/2000SE |
| K000755 | Rhigene MESACUP2 Test- SMLKP · Traditional | 05/09/2000SE |
Questions and answers
When was Rhigene MESACUP2 Test- RNP cleared by the FDA?
Rhigene MESACUP2 Test- RNP (K000752) received a 510(k) decision of Substantially Equivalent on May 9, 2000, 62 days after the submission was received.
What is the product code of K000752?
The FDA product code is LKO – Anti-Rnp Antibody, Antigen And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.