Immunalysis Ethyl Alcohol Enzyme Assay
K-Number: K181553 · 2018-10-31
ApplicantImmunalysis Corporation
Decision Date2018-10-31
Product CodeDIC
Advisory CommitteeTX
DecisionSubstantially Equivalent
Device Summary
Immunalysis Ethyl Alcohol Enzyme Assay is a medical device manufactured by Immunalysis Corporation. It received FDA 510(k) clearance on 2018-10-31 under approval number K181553. The device is classified under product code DIC. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Immunalysis Ethyl Alcohol Enzyme Assay?
Immunalysis Ethyl Alcohol Enzyme Assay is a medical device that received FDA 510(k) clearance on 2018-10-31. It is manufactured by Immunalysis Corporation. The 510(k) number is K181553.
When was Immunalysis Ethyl Alcohol Enzyme Assay approved by the FDA?
Immunalysis Ethyl Alcohol Enzyme Assay received FDA 510(k) clearance on 2018-10-31, under approval number K181553.
What company makes Immunalysis Ethyl Alcohol Enzyme Assay?
Immunalysis Ethyl Alcohol Enzyme Assay is manufactured by Immunalysis Corporation.
What is the FDA product code for Immunalysis Ethyl Alcohol Enzyme Assay?
The FDA product code for Immunalysis Ethyl Alcohol Enzyme Assay is DIC.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.