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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 7 of 7 Results
ProductCode: JJY Applicant: BIOSITE INCORPORATED Decision Date To: 06/10/2024
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lipid controls; multi- analyte control; multi-analyte calibration verification materials ALERE, SAN DIEGO, DBA BIOSITE INCORPORATED, DBA IN K102700 12/21/2010
triage total 3 controls and calibration verification set BIOSITE INCORPORATED K093032 11/13/2009
triage total controls 5, triage total calibration verification 5 BIOSITE INCORPORATED K072892 12/07/2007
triage profiler s.o.b. controls and s.o.b. calibration verification controls BIOSITE INCORPORATED K040459 07/06/2004
triage cardiac controls; triage cardio profiler controls BIOSITE INCORPORATED K030089 01/23/2003
triage cardiac calibration verification controls, triage cardio profiler calibration verficication controls BIOSITE INCORPORATED K030088 01/17/2003
triage(r) cardiac panel calibration verification controls, triag (r) myoglobin calibration verification controls, triage BIOSITE INCORPORATED K974827 01/08/1998
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