FDA 510(k) Applications for Medical Device Product Code "LRM"
(Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K984396 | BIO-RAD | LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213 | 12/18/1998 |
| K952567 | COGENT DIAGNOTICS LTD. | AUTOSTATTMII ANTI-DSDNA | 03/04/1997 |
| K994424 | DIAMEDIX CORP. | DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM | 02/18/2000 |
| K974694 | DIAMEDIX CORP. | IS-DSDNA TEST SYSTEM | 03/03/1998 |
| K083381 | EUROIMMUN US INC | EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG) | 04/15/2009 |
| K960091 | HELIX DIAGNOSTICS, INC. | ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT | 03/20/1996 |
| K001900 | HELIX DIAGNOSTICS, INC. | ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST | 09/11/2000 |
| K962730 | HYCOR BIOMEDICAL, INC. | HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY | 03/07/1997 |
| K954893 | HYCOR BIOMEDICAL, INC. | HYTEC AUTOMIMMUNE KIT (DS-DNA) | 03/20/1996 |
| K101319 | IMMCO DIAGNOSTICS, INC. | IMMULISA DSDNA ANTIBODY ELISA | 12/09/2010 |
| K960182 | MARDX DIAGNOSTICS, INC. | DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM | 03/20/1996 |
| K000477 | MICRO DETECT, INC. | MDI DS-DNA TEST | 03/01/2000 |
| K040811 | PHARMACIA DEUTSCHLAND GMBH | VARELISA SSDNA ANTIBODIES, MODEL 14896 | 05/13/2004 |
| K980391 | QUEST INTL., INC. | SERAQUEST ANTI-DSDNA | 04/24/1998 |
| K993727 | THE BINDING SITE, LTD. | BINDAZYME ANTI-DSDNA EIA KIT | 12/21/1999 |
| K062183 | THE BINDING SITE, LTD. | FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT | 11/21/2006 |
| K983422 | ZEUS SCIENTIFIC, INC. | THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET | 11/18/1998 |
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