The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Architect Galectin-3 Reagent Kit, Architect Galectin-3 Calibrators, Architect Galectin-3 Controls.
| Device ID | K140436 |
| 510k Number | K140436 |
| Device Name: | ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS |
| Classification | Galectin-3 In Vitro Diagnostic Assay |
| Applicant | FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. Malvern, PA 19355 -1307 |
| Contact | Stacey Dolan |
| Correspondent | Stacey Dolan FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. Malvern, PA 19355 -1307 |
| Product Code | OSX |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1117 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-21 |
| Decision Date | 2014-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740096618 | K140436 | 000 |
| 00380740096144 | K140436 | 000 |
| 00380740096137 | K140436 | 000 |