The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Architect Tacrolimus: Model 1l77.
| Device ID | K070820 |
| 510k Number | K070820 |
| Device Name: | ARCHITECT TACROLIMUS: MODEL 1L77 |
| Classification | Enzyme Immunoassay, Tracrolimus |
| Applicant | FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. Malvern, PA 19355 -1307 |
| Contact | Diana Dickson |
| Correspondent | Diana Dickson FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. Malvern, PA 19355 -1307 |
| Product Code | MLM |
| CFR Regulation Number | 862.1678 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-26 |
| Decision Date | 2007-08-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740081911 | K070820 | 000 |
| 00380740001384 | K070820 | 000 |
| 00380740001377 | K070820 | 000 |
| 00380740001360 | K070820 | 000 |
| 00380740168209 | K070820 | 000 |
| 00380740154516 | K070820 | 000 |
| 00380740154240 | K070820 | 000 |