DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL)
FDA 510(k) clearance K102772 · decided 2011-10-07
Clearance details
- K-number
- K102772
- Device name
- DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL)
- Applicant
- Siemens Heatlhcare Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-09-24
- Decision date
- 2011-10-07
- Days to decision
- 378 days
- Clearance type
- Traditional
- Product code
- OAV
- Device class
- 2
- Regulation number
- 862.3840
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Newark, DE, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLS (K081083) | Thermo Fisher Scientific | 2008-12-19 |
| ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS (K063520) | Roche Diagnostics | 2007-02-16 |
Recalls involving this device
No recalls on record reference this clearance.