The following data is part of a premarket notification filed by Mardx, Inc. with the FDA for Mardx Lyme Disease Ifa (igm) Test System.
| Device ID | K894609 |
| 510k Number | K894609 |
| Device Name: | MARDX LYME DISEASE IFA (IGM) TEST SYSTEM |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | MARDX, INC. 847 JERUSALEM RD. Scotch Plains, NJ 07076 |
| Contact | Arthur Markovits |
| Correspondent | Arthur Markovits MARDX, 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 | 1989-07-20 |
| Decision Date | 1989-09-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516746380 | K894609 | 000 |
| 05391516746199 | K894609 | 000 |