The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Lumipulse G E2-iii Calibrators.
Device ID | K163053 |
510k Number | K163053 |
Device Name: | Lumipulse G E2-III Calibrators |
Classification | Calibrator, Secondary |
Applicant | Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern, PA 19355 |
Contact | Stacey Dolan |
Correspondent | Stacey Dolan Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern, PA 19355 |
Product Code | JIT |
CFR Regulation Number | 862.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-11-01 |
Decision Date | 2016-12-01 |
Summary: | summary |