The following data is part of a premarket notification filed by Ibl-hamburg Gmbh with the FDA for Acetylcholine Receptor Ab (arab)rra.
| Device ID | K051144 |
| 510k Number | K051144 |
| Device Name: | ACETYLCHOLINE RECEPTOR AB (ARAB)RRA |
| Classification | Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-blocking |
| Applicant | IBL-HAMBURG GMBH 150 CHERRY LANE RD. East Stroudsburg, PA 18301 |
| Contact | Gary Lehnus |
| Correspondent | Gary Lehnus IBL-HAMBURG GMBH 150 CHERRY LANE RD. East Stroudsburg, PA 18301 |
| Product Code | NST |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-04 |
| Decision Date | 2005-11-18 |
| Summary: | summary |