The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Lumipulse G Tp-n Immunoreaction Cartridge Set.
Device ID | K153145 |
510k Number | K153145 |
Device Name: | Lumipulse G TP-N Immunoreaction Cartridge Set |
Classification | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum |
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 | LIP |
CFR Regulation Number | 866.3830 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-10-30 |
Decision Date | 2016-07-05 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04987270235041 | K153145 | 000 |