MAS TOX CONTROL
FDA 510(k) clearance K080085 · decided 2008-04-30
Clearance details
- K-number
- K080085
- Device name
- MAS TOX CONTROL
- Applicant
- Thermo Fisher Scientific
- Decision
- Substantially Equivalent
- Date received
- 2008-01-11
- Decision date
- 2008-04-30
- Days to decision
- 110 days
- Clearance type
- Traditional
- Product code
- DIF
- Device class
- 1
- Regulation number
- 862.3280
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Fremont Blvd., CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.