K063520 is an FDA 510(k) clearance for the ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS. This device is classified as a Mycophenolic Acid Test System (Class II - Special Controls, product code OAV).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on February 16, 2007, 87 days after receiving the submission on November 21, 2006.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3840. An In Vitro Diagnostic Reagent System Intended For Use In The Quantitative Determination Of Total Mycophenolic Acid In Human Serum Or Plasma As An Aid In The Management Of Mycophenolic Acid Therapy In Renal And Cardiac Transplant Patients..
| 510(k) Number | K063520 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 2006 |
| Decision Date | February 16, 2007 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | OAV — Mycophenolic Acid Test System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3840 |
| Definition | An In Vitro Diagnostic Reagent System Intended For Use In The Quantitative Determination Of Total Mycophenolic Acid In Human Serum Or Plasma As An Aid In The Management Of Mycophenolic Acid Therapy In Renal And Cardiac Transplant Patients. |