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U.S. Department of Health and Human Services

510(k) Premarket Notification
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ProductCode: OCC Applicant: FOCUS DIAGNOSTICS, INC. Decision Date To: 09/20/2024
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simplexa flu a/b & rsv direct and simplexa flu a/b & rsv positive control pack FOCUS DIAGNOSTICS, INC. K152408 09/21/2015
simplexa flu a/b & rsv direct, simplexa flu a/b & rsv positive control pack FOCUS DIAGNOSTICS, INC. K120413 07/13/2012
simplexa flu a/b & rsv FOCUS DIAGNOSTICS, INC. K102170 11/24/2010
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