Panels › Immunology › Product code LKO · Class 2
Anti-Rnp Antibody, Antigen And Control
Regulation 866.5100
0510(k)s in 12 months (23 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in LKO
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 25, 2019 | K191085 | Maverick RNP Assay and Maverick Diagnostic System Genalyte, Inc. | LKO |
| Dec 9, 2014 | K140224 | EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG) Euroimmun US | LKO |
| Jun 12, 2013 | K123261 | EUROIMMUN ANTI-NRNP/SM ELISA (IGG) Euroimmun US | LKO |
| May 28, 2009 | 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. | LKO |
| Dec 19, 2007 | K071210 | MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006 Biomedical Diagnostics (Bmd) SA, FR | LKO |
| Aug 14, 2002 | K022017 | RHIGENE MESACUP-2 TEST RNP, MODEL M7741 Rhigene, Inc. | LKO |
| May 9, 2000 | K000752 | RHIGENE MESACUP2 TEST- RNP Rhigene, Inc. | LKO |
| Nov 26, 1999 | K993589 | VARELISA RNP ANTIBODIES Pharmacia & Upjohn Co. | LKO |
| Apr 28, 1999 | K990624 | AUTOSTAT II ANTI-SM/RNP ELISA Cogent Diagnotics , Ltd., GB | LKO |
| Dec 22, 1998 | K984476 | LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207 Bio-Rad | LKO |
| Nov 18, 1998 | K983465 | THE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE Zeus Scientific, Inc. | LKO |
| May 8, 1996 | K954831 | ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY Orgentec | LKO |
| Mar 22, 1996 | K954897 | HYTEC AUTOIMMUNE KITS (RNP) Hycor Biomedical, Inc. | LKO |
| Apr 20, 1994 | K940588 | ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT Helix Diagnostics, Inc. | LKO |
| May 11, 1993 | K930142 | SYNELISA U1-SNRNP (68KDA)-ANTIBODIES Elias U.S.A., Inc. | LKO |
| May 7, 1991 | K911850 | IMMUNWELL SJOGREN`S SYNDROME B (LA) ANTIBODY TEST General Biometrics, Inc. | LKO |
| May 7, 1991 | K911849 | IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST General Biometrics, Inc. | LKO |
| Dec 13, 1990 | K905194 | DIASTAT ANTI-RO (SS-A) Shield Diagnostics, Ltd., KN | LKO |
| Dec 13, 1990 | K905193 | DIASTAT ANTI-LA (SS-B) Shield Diagnostics, Ltd., KN | LKO |
| Nov 6, 1989 | K895997 | RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES Lipogen, Inc. | LKO |
| Oct 17, 1989 | K895338 | ANTI-RNP AND ANTI-SM ANTIBODY TEST Immco Diagnostics, Inc. | LKO |
| Mar 11, 1988 | K874152 | RNP ANTIBODY TEST KIT Lipogen, Inc. | LKO |
| Jul 18, 1983 | K831292 | ANTI-ENA TEST Meloy Laboratories, Inc. | LKO |
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