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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 6 of 6 Results
ProductCode: MMI Applicant: BIOSITE INCORPORATED Decision Date To: 05/21/2022
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triage cardioprofiler and profiler s.o.b. panels BIOSITE INCORPORATED K080269 06/06/2008
trigage profiler s.o.b. panel, model 97300 BIOSITE INCORPORATED K042723 12/07/2004
triage profiler s.o.b. panel BIOSITE INCORPORATED K040437 06/25/2004
triage cardio profiler/triage cardiac panel BIOSITE INCORPORATED K030286 02/21/2003
triage statmeter BIOSITE INCORPORATED K973547 01/13/1998
triage cardiac panel, triage troponin-i, triage ck-mb, triage myoglobin, triage troponin-i and ck-mb, triage troponin-i BIOSITE INCORPORATED K973126 10/06/1997