The following data is part of a premarket notification filed by Immunetics, Inc. with the FDA for Quickelisa Anthrax-pa Kit.
| Device ID | K040407 |
| 510k Number | K040407 |
| Device Name: | QUICKELISA ANTHRAX-PA KIT |
| Classification | Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis |
| Applicant | IMMUNETICS, INC. 27 DRYDOCK AVENUE Boston, MA 02210 |
| Contact | Andrew Levin |
| Correspondent | Andrew Levin IMMUNETICS, INC. 27 DRYDOCK AVENUE Boston, MA 02210 |
| Product Code | NRL |
| CFR Regulation Number | 866.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-17 |
| Decision Date | 2004-06-03 |
| Summary: | summary |