LRM — Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control Class II
FDA product code LRM covers "Anti-Dna Antibody (Enzyme-Labeled), Antigen, 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
- LRM
- 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 |
|---|---|---|---|
| K101319 | immco diagnostics | IMMULISA DSDNA ANTIBODY ELISA | December 9, 2010 |
| K083381 | euroimmun us | EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG) | April 15, 2009 |
| K062183 | binding site | FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT | November 21, 2006 |
| K040811 | pharmacia deutschland | VARELISA SSDNA ANTIBODIES, MODEL 14896 | May 13, 2004 |
| K001900 | helix diagnostics | ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST | September 11, 2000 |
| K000477 | micro detect | MDI DS-DNA TEST | March 1, 2000 |
| K994424 | diamedix | DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM | February 18, 2000 |
| K993727 | binding site | BINDAZYME ANTI-DSDNA EIA KIT | December 21, 1999 |
| K984396 | bio-rad | LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213 | December 18, 1998 |
| K983422 | zeus scientific | THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUN | November 18, 1998 |
| K980391 | quest intl | SERAQUEST ANTI-DSDNA | April 24, 1998 |
| K974694 | diamedix | IS-DSDNA TEST SYSTEM | March 3, 1998 |
| K962730 | hycor biomedical | HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY | March 7, 1997 |
| K952567 | cogent diagnotics | AUTOSTATTMII ANTI-DSDNA | March 4, 1997 |
| K960182 | mardx diagnostics | DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM | March 20, 1996 |
| K954893 | hycor biomedical | HYTEC AUTOMIMMUNE KIT (DS-DNA) | March 20, 1996 |
| K960091 | helix diagnostics | ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT | March 20, 1996 |
| K953671 | orgentec | ORGEN TEC ANTI-DSDNA ELISA ASSAY | November 9, 1995 |
| K952055 | american laboratory products co | ORGEN TEC ANTI-DSDNA PIN IMMUNO ASSAY | July 18, 1995 |
| K944334 | elias u.s.a | VARELISA COMBINED DNA ANTIBODIES EIA | April 17, 1995 |