FDA Product Code
FDA Product Code LKO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5100
510(k) Clearances — 23 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K191085 | Maverick RNP Assay and Maverick Diagnostic System | Genalyte, Inc. | 2019-10-25 | Traditional | PDF ↗ |
| K140224 | EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG) | Euroimmun US | 2014-12-09 | Traditional | PDF ↗ |
| K123261 | EUROIMMUN ANTI-NRNP/SM ELISA (IGG) | Euroimmun US | 2013-06-12 | Traditional | PDF ↗ |
| K083117 | ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01 | Phadia US, Inc. | 2009-05-28 | Traditional | PDF ↗ |
| K071210 | MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006 | Biomedical Diagnostics (Bmd) SA | 2007-12-19 | Traditional | PDF ↗ |
| K022017 | RHIGENE MESACUP-2 TEST RNP, MODEL M7741 | Rhigene, Inc. | 2002-08-14 | Traditional | PDF ↗ |
| K000752 | RHIGENE MESACUP2 TEST- RNP | Rhigene, Inc. | 2000-05-09 | Traditional | PDF ↗ |
| K993589 | VARELISA RNP ANTIBODIES | Pharmacia & Upjohn Co. | 1999-11-26 | Traditional | PDF ↗ |
| K990624 | AUTOSTAT II ANTI-SM/RNP ELISA | Cogent Diagnotics , Ltd. | 1999-04-28 | Traditional | PDF ↗ |
| K984476 | LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207 | Bio-Rad | 1998-12-22 | Traditional | PDF ↗ |
| K983465 | THE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE | Zeus Scientific, Inc. | 1998-11-18 | Traditional | PDF ↗ |
| K954831 | ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY | Orgentec | 1996-05-08 | Traditional | PDF ↗ |
| K954897 | HYTEC AUTOIMMUNE KITS (RNP) | Hycor Biomedical, Inc. | 1996-03-22 | Traditional | PDF ↗ |
| K940588 | ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT | Helix Diagnostics, Inc. | 1994-04-20 | Traditional | PDF ↗ |
| K930142 | SYNELISA U1-SNRNP (68KDA)-ANTIBODIES | Elias U.S.A., Inc. | 1993-05-11 | Traditional | PDF ↗ |
| K911849 | IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST | General Biometrics, Inc. | 1991-05-07 | Traditional | PDF ↗ |
| K911850 | IMMUNWELL SJOGREN`S SYNDROME B (LA) ANTIBODY TEST | General Biometrics, Inc. | 1991-05-07 | Traditional | PDF ↗ |
| K905194 | DIASTAT ANTI-RO (SS-A) | Shield Diagnostics, Ltd. | 1990-12-13 | Traditional | PDF ↗ |
| K905193 | DIASTAT ANTI-LA (SS-B) | Shield Diagnostics, Ltd. | 1990-12-13 | Traditional | PDF ↗ |
| K895997 | RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES | Lipogen, Inc. | 1989-11-06 | Traditional | PDF ↗ |
| K895338 | ANTI-RNP AND ANTI-SM ANTIBODY TEST | Immco Diagnostics, Inc. | 1989-10-17 | Traditional | PDF ↗ |
| K874152 | RNP ANTIBODY TEST KIT | Lipogen, Inc. | 1988-03-11 | Traditional | PDF ↗ |
| K831292 | ANTI-ENA TEST | Meloy Laboratories, Inc. | 1983-07-18 | Traditional | PDF ↗ |
Product code LKO · Class II · Immunology. Data: openFDA.