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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 23 Results
ProductCode: GKZ Applicant: ABBOTT LABORATORIES Decision Date To: 05/02/2024
 
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abbott cell-dyn 3000 series hematology systems ABBOTT LABORATORIES K980614 04/24/1998
abbott cell-dyn 3200 system ABBOTT LABORATORIES K972354 09/16/1997
abbott cell-dyn 4000 immature reticulocyte fraction (irf) ABBOTT LABORATORIES K971152 08/12/1997
abbott cell-dyn 4000 immunopit (cd61) assay ABBOTT LABORATORIES K981342 06/29/1998
abbott encounter(tm)q ABBOTT LABORATORIES K930309 07/14/1993
adc-500 automated differ. cell cntr. sy. ABBOTT LABORATORIES K803219 01/21/1981
add of reticulocyte count/capabilities ABBOTT LABORATORIES K800533 04/04/1980
alinity h-series system Abbott Laboratories K220031 08/04/2023
auto differential cell counter system ABBOTT LABORATORIES K770244 08/04/1977
cell dyn 3000 multi-parameter automated hematology analyzer (modification) ABBOTT LABORATORIES K955673 05/20/1996
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