The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Architect Cyclosporine.
| Device ID | K080751 |
| 510k Number | K080751 |
| Device Name: | ARCHITECT CYCLOSPORINE |
| Classification | Cyclosporine |
| Applicant | FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. Malvern, PA 19355 -1307 |
| Contact | Stacey Moll |
| Correspondent | Stacey Moll FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. Malvern, PA 19355 -1307 |
| Product Code | MKW |
| CFR Regulation Number | 862.1235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-18 |
| Decision Date | 2008-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740001322 | K080751 | 000 |
| 00380740001315 | K080751 | 000 |
| 00380740001308 | K080751 | 000 |