The following data is part of a premarket notification filed by Kronus Market Development Associates, Inc. with the FDA for Kronus, Inc.'s Acetylcholine Receptor Antibody (achrab) Assay Kit.
| Device ID | K042248 |
| 510k Number | K042248 |
| Device Name: | KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KIT |
| Classification | Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-blocking |
| Applicant | KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. 12554 WEST BRIDGER ST. SUITE 108 Boise, ID 83713 |
| Contact | Heather Viele |
| Correspondent | Heather Viele KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. 12554 WEST BRIDGER ST. SUITE 108 Boise, ID 83713 |
| Product Code | NST |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-19 |
| Decision Date | 2004-12-17 |