Product code LKO
- Device name
- Anti-Rnp Antibody, Antigen And Control
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5100
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K191085 | Maverick RNP Assay and Maverick Diagnostic System | Genalyte, Inc. | 2019-10-25 |
| K140224 | EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG) | Euroimmun US | 2014-12-09 |
| K123261 | EUROIMMUN ANTI-NRNP/SM ELISA (IGG) | Euroimmun US | 2013-06-12 |
| 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 |
| K071210 | MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006 | Biomedical Diagnostics (Bmd) SA | 2007-12-19 |
| K022017 | RHIGENE MESACUP-2 TEST RNP, MODEL M7741 | Rhigene, Inc. | 2002-08-14 |
| K000752 | RHIGENE MESACUP2 TEST- RNP | Rhigene, Inc. | 2000-05-09 |
| K993589 | VARELISA RNP ANTIBODIES | Pharmacia & Upjohn Co. | 1999-11-26 |
| K990624 | AUTOSTAT II ANTI-SM/RNP ELISA | Cogent Diagnotics , Ltd. | 1999-04-28 |
| K984476 | LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207 | Bio-Rad | 1998-12-22 |
| 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 |
| K954831 | ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY | Orgentec | 1996-05-08 |
| K954897 | HYTEC AUTOIMMUNE KITS (RNP) | Hycor Biomedical, Inc. | 1996-03-22 |
| K940588 | ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT | Helix Diagnostics, Inc. | 1994-04-20 |
| K930142 | SYNELISA U1-SNRNP (68KDA)-ANTIBODIES | Elias U.S.A., Inc. | 1993-05-11 |
| K911849 | IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST | General Biometrics, Inc. | 1991-05-07 |
| K911850 | IMMUNWELL SJOGREN`S SYNDROME B (LA) ANTIBODY TEST | General Biometrics, Inc. | 1991-05-07 |
| K905193 | DIASTAT ANTI-LA (SS-B) | Shield Diagnostics, Ltd. | 1990-12-13 |
| K905194 | DIASTAT ANTI-RO (SS-A) | Shield Diagnostics, Ltd. | 1990-12-13 |
| K895997 | RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES | Lipogen, Inc. | 1989-11-06 |
| K895338 | ANTI-RNP AND ANTI-SM ANTIBODY TEST | Immco Diagnostics, Inc. | 1989-10-17 |
| K874152 | RNP ANTIBODY TEST KIT | Lipogen, Inc. | 1988-03-11 |
| K831292 | ANTI-ENA TEST | Meloy Laboratories, Inc. | 1983-07-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
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| 00816879020328 | Autostat II Anti-Sm/RNP | HYCOR BIOMEDICAL LLC | 2016-09-26 |
| 04049016083139 | EUROLINE ENA ProfilePlus 4 (IgG) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016084785 | EUROLINE ENA ProfilePlus 4 (IgG) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016124900 | EUROLINE ENA Profile 9 Ag (IgG) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016124917 | EUROLINE ENA Profile 9 Ag (IgG) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016027010 | Anti-nRNP/Sm ELISA (IgG) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 07333066014623 | EliA RNP70 Well | Phadia AB | 2016-09-23 |
| 07333066010663 | EliA RNP70 Well | Phadia AB | 2016-09-23 |
| 00847865002721 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865002448 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865001342 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865000086 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847817022456 | Autoimmune EIA | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865012331 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865000093 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 08426950595151 | QUANTA Flash® RNP Reagents | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 07340058410011 | DIASTAT anti-La (SS-B) | Svar Life Science AB | 2016-08-12 |
| 07340058410004 | DIASTAT anti-Ro (SS-A) | Svar Life Science AB | 2016-08-12 |