The following data is part of a premarket notification filed by Mardx Diagnostics, Inc. with the FDA for Mardx Lyme Disease (igg) Marblot Strip Test System.
| Device ID | K950829 |
| 510k Number | K950829 |
| Device Name: | MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM |
| Classification | Reagent, Borrelia Serological Reagent |
| 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 | LSR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-23 |
| Decision Date | 1996-06-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516747967 | K950829 | 000 |
| 05391516746229 | K950829 | 000 |
| 05391516746236 | K950829 | 000 |
| 05391516747615 | K950829 | 000 |
| 05391516747622 | K950829 | 000 |
| 05391516747639 | K950829 | 000 |
| 05391516747653 | K950829 | 000 |
| 05391516747660 | K950829 | 000 |
| 05391516747707 | K950829 | 000 |
| 05391516746205 | K950829 | 000 |