LZI Cotinine II Enzyme Immunoassay
K-Number: K192299 · 2019-11-21
ApplicantLin-Zhi International, Inc.
Decision Date2019-11-21
Product CodeMKU
Advisory CommitteeTX
DecisionSubstantially Equivalent
Device Summary
LZI Cotinine II Enzyme Immunoassay is a medical device manufactured by Lin-Zhi International, Inc.. It received FDA 510(k) clearance on 2019-11-21 under approval number K192299. The device is classified under product code MKU. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the LZI Cotinine II Enzyme Immunoassay?
LZI Cotinine II Enzyme Immunoassay is a medical device that received FDA 510(k) clearance on 2019-11-21. It is manufactured by Lin-Zhi International, Inc.. The 510(k) number is K192299.
When was LZI Cotinine II Enzyme Immunoassay approved by the FDA?
LZI Cotinine II Enzyme Immunoassay received FDA 510(k) clearance on 2019-11-21, under approval number K192299.
What company makes LZI Cotinine II Enzyme Immunoassay?
LZI Cotinine II Enzyme Immunoassay is manufactured by Lin-Zhi International, Inc..
What is the FDA product code for LZI Cotinine II Enzyme Immunoassay?
The FDA product code for LZI Cotinine II Enzyme Immunoassay is MKU.
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Official Source
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