The following data is part of a premarket notification filed by Boston Biomedica, Inc. with the FDA for Accurun(tm) 132 Borrelia Burdorferi Igm Positive Control.
| Device ID | K974810 |
| 510k Number | K974810 |
| Device Name: | ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | BOSTON BIOMEDICA, INC. 375 WEST ST. West Bridgewater, MA 02379 |
| Contact | Patricia E Garrett |
| Correspondent | Patricia E Garrett 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 | 1997-12-23 |
| Decision Date | 1998-02-05 |
| Summary: | summary |