The following data is part of a premarket notification filed by Chembio Diagnostic Systems, Inc. with the FDA for Prevue(tm) Borrelia Burgdorferi Antibody Detection Assay.
| Device ID | K981913 |
| 510k Number | K981913 |
| Device Name: | PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | Chembio Diagnostic Systems, Inc. 25 EAST LOOP RD. Stoneybrook, NY 11790 |
| Contact | Raymond Dattwyler |
| Correspondent | Raymond Dattwyler Chembio Diagnostic Systems, Inc. 25 EAST LOOP RD. Stoneybrook, NY 11790 |
| Product Code | LSR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-01 |
| Decision Date | 1999-02-12 |
| Summary: | summary |