The following data is part of a premarket notification filed by Immunetics, Inc. with the FDA for Immunetics C6 Lyme Elisa Kit.
| Device ID | K003754 |
| 510k Number | K003754 |
| Device Name: | IMMUNETICS C6 LYME ELISA KIT |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | IMMUNETICS, INC. 63 ROGERS ST. Cambridge,, MA 02142 |
| Contact | Andrew E Levin |
| Correspondent | Andrew E Levin IMMUNETICS, INC. 63 ROGERS ST. Cambridge,, MA 02142 |
| Product Code | LSR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-05 |
| Decision Date | 2001-05-10 |