510(k) K960091
- Device
- ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT
- Applicant
- HELIX DIAGNOSTICS, INC.
- 510(k) number
- K960091
- Product code
- LRM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-03-20
- Date received
- 1996-01-11
- Regulation
- 866.5100
- Classification name
- Anti-dna Antibody (enzyme-labeled), Antigen, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- VIRGINIA L CAPPEL
- Address
- 3148 Industrial Blvd. West Sacramento CA US 95691 95691
FDA Registration Numbers#
- 3002800697
- 2026994
- 3007361513
- 3003268355
- 3012348571
- 1318354
- 3007208259
- 1421346
- 2029372
- 2245285
- 3022178699
- 3015376545
- 3007118747
- 2915274
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LRM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K101319 | IMMULISA DSDNA ANTIBODY ELISA | Immco Diagnostics, Inc. | 2010-12-09 |
| K083381 | EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG) | Euroimmun Us, Inc. | 2009-04-15 |
| K062183 | FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT | The Binding Site, Ltd. | 2006-11-21 |
| K040811 | VARELISA SSDNA ANTIBODIES, MODEL 14896 | Pharmacia Deutschland GmbH | 2004-05-13 |
| K001900 | ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST | Helix Diagnostics, Inc. | 2000-09-11 |
| K000477 | MDI DS-DNA TEST | Micro Detect, Inc. | 2000-03-01 |
| K994424 | DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM | Diamedix Corp. | 2000-02-18 |
| K993727 | BINDAZYME ANTI-DSDNA EIA KIT | The Binding Site, Ltd. | 1999-12-21 |
| K984396 | LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213 | Bio-Rad | 1998-12-18 |
| 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 |
| K980391 | SERAQUEST ANTI-DSDNA | Quest Intl., Inc. | 1998-04-24 |
| K974694 | IS-DSDNA TEST SYSTEM | Diamedix Corp. | 1998-03-03 |
| K962730 | HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY | Hycor Biomedical, Inc. | 1997-03-07 |
| K952567 | AUTOSTATTMII ANTI-DSDNA | Cogent Diagnotics , Ltd. | 1997-03-04 |
| K954893 | HYTEC AUTOMIMMUNE KIT (DS-DNA) | Hycor Biomedical, Inc. | 1996-03-20 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases