The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Architect Sirolimus Assay.
| Device ID | K070822 |
| 510k Number | K070822 |
| Device Name: | ARCHITECT SIROLIMUS ASSAY |
| Classification | Sirolimus Test System |
| Applicant | FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PARKWAY Malvern, PA 19355 -1308 |
| Contact | Diana Lyn Dickson |
| Correspondent | Diana Lyn Dickson FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PARKWAY Malvern, PA 19355 -1308 |
| Product Code | NRP |
| CFR Regulation Number | 862.3840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-26 |
| Decision Date | 2007-09-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740001353 | K070822 | 000 |
| 00380740001346 | K070822 | 000 |
| 00380740001339 | K070822 | 000 |
| 00380740154233 | K070822 | 000 |
| 00380740150990 | K070822 | 000 |