Teco Diagnostics Saliva Alcohol Test
FDA 510(k) K111206 · Teco Diagnostics
510(k) numberK111206
Submission
- Device name
- Teco Diagnostics Saliva Alcohol Test
- Applicant
- Teco Diagnostics
Anaheim, CA, US - Received
- April 29, 2011
- Decision date
- October 4, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DIC – Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3040
- Specialty
- Clinical Toxicology
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Questions and answers
When was Teco Diagnostics Saliva Alcohol Test cleared by the FDA?
Teco Diagnostics Saliva Alcohol Test (K111206) received a 510(k) decision of Substantially Equivalent on October 4, 2011, 158 days after the submission was received.
What is the product code of K111206?
The FDA product code is DIC – Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method, a Class II (moderate risk) device regulated under 21 CFR 862.3040.