The following data is part of a premarket notification filed by Mardx Diagnostics, Inc. with the FDA for Mardx Ena Igg Immunostripe Test System / Mardx Ena Igg Marstripe Test System.
| Device ID | K964787 |
| 510k Number | K964787 |
| Device Name: | MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM |
| Classification | Extractable Antinuclear Antibody, Antigen And Control |
| Applicant | MARDX DIAGNOSTICS, INC. 5919 FARNSWORTH CT. Carlsbad, CA 92008 |
| Contact | Arthur Markovits |
| Correspondent | Arthur Markovits MARDX DIAGNOSTICS, INC. 5919 FARNSWORTH CT. Carlsbad, CA 92008 |
| Product Code | LLL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-29 |
| Decision Date | 1997-04-08 |
| Summary: | summary |