Mas Tox Control
FDA 510(k) K080085 · Thermo Fisher Scientific
510(k) numberK080085
Submission
- Device name
- Mas Tox Control
- Applicant
- Thermo Fisher Scientific
Fremont Blvd., CA, US - Received
- January 11, 2008
- Decision date
- April 30, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DIF – Drug Mixture Control Materials
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3280
- Specialty
- Clinical Toxicology
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Questions and answers
When was Mas Tox Control cleared by the FDA?
Mas Tox Control (K080085) received a 510(k) decision of Substantially Equivalent on April 30, 2008, 110 days after the submission was received.
What is the product code of K080085?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.