The following data is part of a premarket notification filed by Mrl Diagnostics with the FDA for Lyme Disease B. Burgdorferi Genogroup 1 Western Blot Igm (wb0400m).
| Device ID | K971007 |
| 510k Number | K971007 |
| Device Name: | LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M) |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | MRL DIAGNOSTICS 10703 PROGRESS WAY Cypress, CA 90630 -4737 |
| Contact | Michael J Wagner |
| Correspondent | Michael J Wagner MRL DIAGNOSTICS 10703 PROGRESS WAY Cypress, CA 90630 -4737 |
| Product Code | LSR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-19 |
| Decision Date | 1998-06-01 |
| Summary: | summary |