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Fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also please note the regulation entitled Misbranding by reference to premarket notification 21 CFR Part 807. 1651-A CROSSINGS PARKWAY WESTLAKE OH 44145 Re K170772 Trade/Device Name Liofilchem MIC Test Strip MTS 0. 016 - 256 g/mL Regulation Number 21 CFR 866. 1640 Regulatory Class II Product Code JWY Dated March 13 2017 Received March 14 2017 Dear Ms. The MTS at concentrations of 0. 016-256 g/mL should be interpreted at 16-20 hours...
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What is liofilchem s?
Liofilchem s is a form used for reporting financial information to regulatory authorities.
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