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 |