Mission Saliva Alcohol Test Strip
FDA 510(k) K093879 · ACON Laboratories, Inc.
510(k) numberK093879
Submission
- Device name
- Mission Saliva Alcohol Test Strip
- Applicant
- ACON Laboratories, Inc.
San Diego, CA, US - Received
- December 18, 2009
- Decision date
- August 6, 2010
- 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 Mission Saliva Alcohol Test Strip cleared by the FDA?
Mission Saliva Alcohol Test Strip (K093879) received a 510(k) decision of Substantially Equivalent on August 6, 2010, 231 days after the submission was received.
What is the product code of K093879?
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.