The following data is part of a premarket notification filed by Columbia Bioscience, Inc. with the FDA for Is Borrelia Burgdorferi Igg/igm Elisa Test System.
| Device ID | K983605 |
| 510k Number | K983605 |
| Device Name: | IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | COLUMBIA BIOSCIENCE, INC. 8775 M CENTRE PARK DR. #559 Columbia, MD 21045 |
| Contact | Norman Jenkins |
| Correspondent | Norman Jenkins COLUMBIA BIOSCIENCE, INC. 8775 M CENTRE PARK DR. #559 Columbia, MD 21045 |
| Product Code | LSR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-14 |
| Decision Date | 1998-12-16 |
| Summary: | summary |