CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLS— 510(k) K081083
Substantially EquivalentThermo Fisher Scientific
FDA 510(k) clearance K081083 for CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLS, Substantially Equivalent on 2008-12-19. Applicant: Thermo Fisher Scientific. Device class: 2.
Clearance details
- Applicant
- Thermo Fisher Scientific
- Product code
- Code OAV
- Device class
- Class 2
- Regulation
- 21 CFR 862.3840
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fremont Blvd., CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.