The following data is part of a premarket notification filed by Mardx Diagnostics, Inc. with the FDA for Mardx Llyme Disease Eia (igg & Igm) Test System.
| Device ID | K892206 |
| 510k Number | K892206 |
| Device Name: | MARDX LLYME DISEASE EIA (IGG & IGM) TEST SYSTEM |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | MARDX DIAGNOSTICS, INC. 847 JERUSALEM RD. Scotch Plains, NJ 07076 |
| Contact | Arthur Markovits |
| Correspondent | Arthur Markovits MARDX DIAGNOSTICS, INC. 847 JERUSALEM RD. Scotch Plains, NJ 07076 |
| Product Code | LSR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-03 |
| Decision Date | 1989-08-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516746618 | K892206 | 000 |
| 05391516746601 | K892206 | 000 |
| 05391516746304 | K892206 | 000 |
| 05391516746298 | K892206 | 000 |