The following data is part of a premarket notification filed by Immunetics, Inc. with the FDA for Qualicode B. Burgdorferi Igm Western Blot Kit, Model Dk-c062-024.
| Device ID | K991062 |
| 510k Number | K991062 |
| Device Name: | QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-024 |
| 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 | 1999-03-31 |
| Decision Date | 1999-09-21 |
| Summary: | summary |