510(k) K081083
- Device
- CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLS
- Applicant
- Thermo Fisher Scientific
- 510(k) number
- K081083
- Product code
- OAV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-12-19
- Date received
- 2008-04-16
- Regulation
- 862.3840
- Classification name
- Mycophenolic Acid Test System
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JACK ROGERS
- Address
- 46360 Fremont Blvd. Fremont Blvd. CA US 94538 94538
FDA Registration Numbers#
- 3010939897
- 9610126
- 9610529
- 3006198300
- 2517506
- 3003795116
Source Documents#
Other 510(k) Records For Product Code OAV #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K102772 | DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL) | Siemens Heatlhcare Diagnostics, Inc. | 2011-10-07 |
| K063520 | ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS | Roche Diagnostics | 2007-02-16 |
Legacy Summary#
summary
FDA Review#
Decision Summary