The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Lumipulse G Prolactin.
Device ID | K163544 |
510k Number | K163544 |
Device Name: | Lumipulse G Prolactin |
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 | 2016-12-16 |
Decision Date | 2017-01-12 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04987270235195 | K163544 | 000 |