The following data is part of a premarket notification filed by Mardx Diagnostics, Inc. with the FDA for Dsdna Immunoglobulin Eia Test System.
| Device ID | K960182 |
| 510k Number | K960182 |
| Device Name: | DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM |
| Classification | Anti-dna Antibody (enzyme-labeled), Antigen, Control |
| Applicant | MARDX DIAGNOSTICS, INC. 5919 FARNSWORTH CT. Carlsbad, CA 92008 |
| Contact | Barry Menefee |
| Correspondent | Barry Menefee MARDX DIAGNOSTICS, INC. 5919 FARNSWORTH CT. Carlsbad, CA 92008 |
| Product Code | LRM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-16 |
| Decision Date | 1996-03-20 |
| Summary: | summary |