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U.S. Department of Health and Human Services

510(k) Premarket Notification

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11 to 20 of 23 Results
ProductCode: GKZ Applicant: ABBOTT LABORATORIES Decision Date To: 05/02/2024
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cell-dyn 1800 system ABBOTT LABORATORIES K030513 05/12/2003
cell-dyn 1200 system ABBOTT LABORATORIES K991142 06/23/1999
cell dyn 3500 multi-parameter automated hematology analyzer (modification) ABBOTT LABORATORIES K955715 10/08/1996
cell dyn 3000 multi-parameter automated hematology analyzer (modification) ABBOTT LABORATORIES K955673 05/20/1996
auto differential cell counter system ABBOTT LABORATORIES K770244 08/04/1977
alinity h-series system Abbott Laboratories K220031 08/04/2023
add of reticulocyte count/capabilities ABBOTT LABORATORIES K800533 04/04/1980
adc-500 automated differ. cell cntr. sy. ABBOTT LABORATORIES K803219 01/21/1981
abbott encounter(tm)q ABBOTT LABORATORIES K930309 07/14/1993
abbott cell-dyn 4000 immunopit (cd61) assay ABBOTT LABORATORIES K981342 06/29/1998
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