The following data is part of a premarket notification filed by Genbio with the FDA for Mmuno Dot Borrelia Dot Blot M Test.
| Device ID | K953683 |
| 510k Number | K953683 |
| Device Name: | MMUNO DOT BORRELIA DOT BLOT M TEST |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | GenBio 15222 AVE. OF SCIENCE, SUITE A San Diego, CA 92128 |
| Contact | Bryan Kiehl |
| Correspondent | Bryan Kiehl GenBio 15222 AVE. OF SCIENCE, SUITE A San Diego, CA 92128 |
| Product Code | LSR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-07 |
| Decision Date | 1996-05-03 |