Ethanol Reagent, Ethanol Calibrator, Ethanol QC Material
FDA 510(k) K111005 · Medica Corp.
510(k) numberK111005
Submission
- Device name
- Ethanol Reagent, Ethanol Calibrator, Ethanol QC Material
- Applicant
- Medica Corp.
Bedford, MA, US - Received
- April 11, 2011
- Decision date
- November 15, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 Ethanol Reagent, Ethanol Calibrator, Ethanol QC Material cleared by the FDA?
Ethanol Reagent, Ethanol Calibrator, Ethanol QC Material (K111005) received a 510(k) decision of Substantially Equivalent on November 15, 2011, 218 days after the submission was received.
What is the product code of K111005?
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.