FDA Product Code
FDA Product Code LRM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5100
510(k) Clearances — 29 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K101319 | IMMULISA DSDNA ANTIBODY ELISA | Immco Diagnostics, Inc. | 2010-12-09 | Traditional | PDF ↗ |
| K083381 | EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG) | Euroimmun Us, Inc. | 2009-04-15 | Traditional | PDF ↗ |
| K062183 | FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT | The Binding Site, Ltd. | 2006-11-21 | Traditional | PDF ↗ |
| K040811 | VARELISA SSDNA ANTIBODIES, MODEL 14896 | Pharmacia Deutschland GmbH | 2004-05-13 | Traditional | PDF ↗ |
| K001900 | ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST | Helix Diagnostics, Inc. | 2000-09-11 | Traditional | PDF ↗ |
| K000477 | MDI DS-DNA TEST | Micro Detect, Inc. | 2000-03-01 | Traditional | PDF ↗ |
| K994424 | DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM | Diamedix Corp. | 2000-02-18 | Traditional | PDF ↗ |
| K993727 | BINDAZYME ANTI-DSDNA EIA KIT | The Binding Site, Ltd. | 1999-12-21 | Traditional | PDF ↗ |
| K984396 | LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213 | Bio-Rad | 1998-12-18 | Traditional | PDF ↗ |
| K983422 | THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET | Zeus Scientific, Inc. | 1998-11-18 | Traditional | PDF ↗ |
| K980391 | SERAQUEST ANTI-DSDNA | Quest Intl., Inc. | 1998-04-24 | Traditional | PDF ↗ |
| K974694 | IS-DSDNA TEST SYSTEM | Diamedix Corp. | 1998-03-03 | Traditional | PDF ↗ |
| K962730 | HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY | Hycor Biomedical, Inc. | 1997-03-07 | Traditional | PDF ↗ |
| K952567 | AUTOSTATTMII ANTI-DSDNA | Cogent Diagnotics , Ltd. | 1997-03-04 | Traditional | PDF ↗ |
| K960182 | DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM | Mardx Diagnostics, Inc. | 1996-03-20 | Traditional | PDF ↗ |
| K954893 | HYTEC AUTOMIMMUNE KIT (DS-DNA) | Hycor Biomedical, Inc. | 1996-03-20 | Traditional | PDF ↗ |
| K960091 | ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT | Helix Diagnostics, Inc. | 1996-03-20 | Traditional | PDF ↗ |
| K953671 | ORGEN TEC ANTI-DSDNA ELISA ASSAY | Orgentec | 1995-11-09 | Traditional | PDF ↗ |
| K952055 | ORGEN TEC ANTI-DSDNA PIN IMMUNO ASSAY | American Laboratory Products Co., Ltd. | 1995-07-18 | Traditional | PDF ↗ |
| K944334 | VARELISA COMBINED DNA ANTIBODIES EIA | Elias U.S.A., Inc. | 1995-04-17 | Traditional | PDF ↗ |
| K950031 | VARELISA DSDNA ANTIBODIES (FARR VERSION) | Elias U.S.A., Inc. | 1995-03-10 | Traditional | PDF ↗ |
| K940585 | SELISA ANTI-N DNA ANTIBODIES | Cambridge Life Sciences Plc. | 1994-06-10 | Traditional | PDF ↗ |
| K923537 | ENCORE DS-DNA | Clark Laboratories, Inc. | 1992-12-23 | Traditional | PDF ↗ |
| K913653 | 3M ANTI-DSDNA FAST TEST | 3M Diagnostic Systems, Inc. | 1991-11-07 | Traditional | PDF ↗ |
| K912020 | ANTI-DNA MICROASSAY | Diamedix Corp. | 1991-09-23 | Traditional | PDF ↗ |
| K902897 | UBI MAGIWEL(TM) ANTI-DS-DNA QUANTITATIVE | United Biotech, Inc. | 1990-07-16 | Traditional | PDF ↗ |
| K893036 | ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS) | Amersham Corp. | 1989-06-02 | Traditional | PDF ↗ |
| K874191 | NDNA ANTIBODY TEST KIT | Lipogen, Inc. | 1987-12-18 | Traditional | PDF ↗ |
| K870903 | IMMUSTRIP(TM) DSDNA ELISA TEST SYSTEM | Immunomedics, Inc. | 1987-05-14 | Traditional | PDF ↗ |
Product code LRM · Class II · Immunology. Data: openFDA.