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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name station, pipetting and diluting, for clinical use
510(k) Number K791324
Device Name MICROMEDIC APS2
Original Applicant
MICROMEDIC SYSTEMS
Regulation Number862.2750
Classification Product Code
JQW  
Date Received07/16/1979
Decision Date 08/28/1979
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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