K081083 is an FDA 510(k) clearance for the CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLS. This device is classified as a Mycophenolic Acid Test System (Class II - Special Controls, product code OAV).
Submitted by Thermo Fisher Scientific (Fremont Blvd., US). The FDA issued a Cleared decision on December 19, 2008, 247 days after receiving the submission on April 16, 2008.
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 | K081083 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 16, 2008 |
| Decision Date | December 19, 2008 |
| Days to Decision | 247 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. |