The following data is part of a premarket notification filed by Wampole Laboratories with the FDA for Borrelia Burgdorferi Igm Elisa Test System.
| Device ID | K965129 |
| 510k Number | K965129 |
| Device Name: | BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | WAMPOLE LABORATORIES DIV. OF CARTER-WALLACE, INC. 366 PRINCETONE-HIGHTSTOWN RD. Cranbury, NJ 08512 |
| Contact | William L Boteler Jr. |
| Correspondent | William L Boteler Jr. WAMPOLE LABORATORIES DIV. OF CARTER-WALLACE, INC. 366 PRINCETONE-HIGHTSTOWN RD. Cranbury, NJ 08512 |
| Product Code | LSR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-23 |
| Decision Date | 1997-03-26 |
| Summary: | summary |