The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Lumipulse G Fsh-n Calibrators.
| Device ID | K163534 |
| 510k Number | K163534 |
| Device Name: | Lumipulse G FSH-N Calibrators |
| Classification | Calibrator, Secondary |
| Applicant | Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern, PA 19355 |
| Contact | Diana Dickerson |
| Correspondent | Diana Dickerson 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 | 2017-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987270235218 | K163534 | 000 |
| 04987270230930 | K163534 | 000 |