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 |