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 |