The following data is part of a premarket notification filed by Ivd Technologies with the FDA for Ivd Technologies Achrab Test Kit.
| Device ID | K091468 |
| 510k Number | K091468 |
| Device Name: | IVD TECHNOLOGIES ACHRAB TEST KIT |
| Classification | Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-blocking |
| Applicant | IVD TECHNOLOGIES 150 CHERRY LANE ROAD East Stroudsburg, PA 18301 |
| Contact | Gary Lehnus |
| Correspondent | Gary Lehnus IVD TECHNOLOGIES 150 CHERRY LANE ROAD 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 | 2009-05-18 |
| Decision Date | 2009-11-20 |