The following data is part of a premarket notification filed by Boston Biomedica, Inc. with the FDA for Bbi-biotech Research Laboratories B. Burgdorferi Igm Western Blot Kit.
| Device ID | K980351 |
| 510k Number | K980351 |
| Device Name: | BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | BOSTON BIOMEDICA, INC. 375 WEST ST. West Bridgewater, MA 02379 |
| Contact | Debra A Petit |
| Correspondent | Debra A Petit BOSTON BIOMEDICA, INC. 375 WEST ST. West Bridgewater, MA 02379 |
| Product Code | LSR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-29 |
| Decision Date | 1999-03-05 |
| Summary: | summary |