The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc with the FDA for Lumipulse G Lh Calibrators.
Device ID | K163521 |
510k Number | K163521 |
Device Name: | Lumipulse G LH Calibrators |
Classification | Calibrator, Secondary |
Applicant | FUJIREBIO DIAGNOSTICS, INC 201 GREAT VALLEY PARKWAY Malvern, PA 19355 |
Contact | Diana Dickson |
Correspondent | Diana Dickson 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 | 2016-12-15 |
Decision Date | 2017-01-12 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04987270235270 | K163521 | 000 |
04987270230916 | K163521 | 000 |