510(k) K063520
- Device
- ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS
- Applicant
- Roche Diagnostics
- 510(k) number
- K063520
- Product code
- OAV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-02-16
- Date received
- 2006-11-21
- 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
- KERWIN KAUFMAN
- Address
- 9115 Hague Rd. Indianapolis IN US 46250 46250
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 |
| K081083 | CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLS | Thermo Fisher Scientific | 2008-12-19 |
Legacy Summary#
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FDA Review#
Decision Summary