The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc with the FDA for Fujirebio Diagnostics Tumor Marker Control Model 108-20.
| Device ID | K101809 |
| 510k Number | K101809 |
| Device Name: | FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | FUJIREBIO DIAGNOSTICS, INC 201 GREAT VALLEY PARKWAY Malvern, PA 19355 -1307 |
| Contact | Stacey Dolan |
| Correspondent | Stacey Dolan FUJIREBIO DIAGNOSTICS, INC 201 GREAT VALLEY PARKWAY Malvern, PA 19355 -1307 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-29 |
| Decision Date | 2010-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17350066140043 | K101809 | 000 |