LKO — Anti-Rnp Antibody, Antigen And Control Class II
FDA product code LKO covers "Anti-Rnp Antibody, Antigen And Control", a Class II medical device regulated under 21 CFR 866.5100. Submissions are reviewed by the Immunology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LKO
- Device Class
- Class II
- Regulation Number
- 866.5100
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K191085 | genalyte | Maverick RNP Assay and Maverick Diagnostic System | October 25, 2019 |
| K140224 | euroimmun us | EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG) | December 9, 2014 |
| K123261 | euroimmun us | EUROIMMUN ANTI-NRNP/SM ELISA (IGG) | June 12, 2013 |
| K083117 | phadia us | ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODEL | May 28, 2009 |
| K071210 | biomedical diagnostics (bmd) | MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006 | December 19, 2007 |
| K022017 | rhigene | RHIGENE MESACUP-2 TEST RNP, MODEL M7741 | August 14, 2002 |
| K000752 | rhigene | RHIGENE MESACUP2 TEST- RNP | May 9, 2000 |
| K993589 | pharmacia and upjohn | VARELISA RNP ANTIBODIES | November 26, 1999 |
| K990624 | cogent diagnotics | AUTOSTAT II ANTI-SM/RNP ELISA | April 28, 1999 |
| K984476 | bio-rad | LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207 | December 22, 1998 |
| K983465 | zeus scientific | THE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME LIN | November 18, 1998 |
| K954831 | orgentec | ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY | May 8, 1996 |
| K954897 | hycor biomedical | HYTEC AUTOIMMUNE KITS (RNP) | March 22, 1996 |
| K940588 | helix diagnostics | ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT | April 20, 1994 |
| K930142 | elias u.s.a | SYNELISA U1-SNRNP (68KDA)-ANTIBODIES | May 11, 1993 |
| K911850 | general biometrics | IMMUNWELL SJOGREN`S SYNDROME B (LA) ANTIBODY TEST | May 7, 1991 |
| K911849 | general biometrics | IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST | May 7, 1991 |
| K905193 | shield diagnostics | DIASTAT ANTI-LA (SS-B) | December 13, 1990 |
| K905194 | shield diagnostics | DIASTAT ANTI-RO (SS-A) | December 13, 1990 |
| K895997 | lipogen | RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES | November 6, 1989 |