The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Lumipulse G 25-oh Vitamin D, Lumipulse G 25-oh Vitamin D Calibrators.
Device ID | K153361 |
510k Number | K153361 |
Device Name: | Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators |
Classification | System, Test, Vitamin D |
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 | MRG |
CFR Regulation Number | 862.1825 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-11-20 |
Decision Date | 2016-04-15 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04987270235089 | K153361 | 000 |
04987270234020 | K153361 | 000 |