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In addition FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. SUSAN ROLIH EVP REGULATORY AND QUALITY SYSTEMS 3471 RIVER HILLS DR CINCINNATI OH 45244 November 9 2015 Re K152285 Trade/Device...

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What is meridian bioscience inc?

Meridian Bioscience Inc is a life science company that develops, manufactures, and distributes diagnostic test kits.

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