Dimension Vista Ethyl Alcohol (Alc), Alkaline Phosphatase (Alp), Calcium (CA0 Flex, Lactic Acid (la) Flex Reagent Cartri
FDA 510(k) K061792 · Dade Behring, Inc.
510(k) numberK061792
Submission
- Device name
- Dimension Vista Ethyl Alcohol (Alc), Alkaline Phosphatase (Alp), Calcium (CA0 Flex, Lactic Acid (la) Flex Reagent Cartri
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- June 26, 2006
- Decision date
- July 18, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 Dimension Vista Ethyl Alcohol (Alc), Alkaline Phosphatase (Alp), Calcium (CA0 Flex, Lactic Acid (la) Flex Reagent Cartri cleared by the FDA?
Dimension Vista Ethyl Alcohol (Alc), Alkaline Phosphatase (Alp), Calcium (CA0 Flex, Lactic Acid (la) Flex Reagent Cartri (K061792) received a 510(k) decision of Substantially Equivalent on July 18, 2006, 22 days after the submission was received.
What is the product code of K061792?
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.