The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Roche Total Mycophenolic Acid Assay, Calibrators And Controls.
| Device ID | K063520 |
| 510k Number | K063520 |
| Device Name: | ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS |
| Classification | Mycophenolic Acid Test System |
| Applicant | Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Contact | Kerwin Kaufman |
| Correspondent | Kerwin Kaufman Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Product Code | OAV |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | LAS |
| CFR Regulation Number | 862.3840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-21 |
| Decision Date | 2007-02-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336133675 | K063520 | 000 |