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Abbott Diagnostics

FDA 510(k) & PMA Approved Devices — 28 products

Total Devices28
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K964185 IMX CA 125LTK1997-11-04 View
510(k) K972182 ABBOTT STREP A CONTROLSMJZ1997-08-13 View
510(k) K961439 ABBOTT CELL-DYN 4000 SYSTEMGKZ1996-10-18 View
510(k) K890491 CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYERGKZ1989-04-18 View
510(k) K881242 CELL-DYN RAPID-LYSE AND HEMOGLOBLINGJZ1988-04-21 View
510(k) K881130 CELL-DYN ISOTONIC DILUENTGIF1988-03-31 View
510(k) K873348 CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.GGK1987-09-09 View
510(k) K873347 CELL-DYN DIFF. SCREEN ISOTONIC DILUENTGIF1987-09-09 View
510(k) K873408 MODEL 690 SPECTROPHOTOMETERJJQ1987-09-08 View
510(k) K872761 CELL-DYN 610 HEMATOLOGY ANALYZERGKZ1987-08-06 View
510(k) K870233 CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZERGKZ1987-03-17 View
510(k) K854368 CELL-DYN 1500 MULTI-PARAMETER HEMATOLOGY ANALYZERGKZ1986-01-01 View
510(k) K852371 CELL-DYN 2000 AUTOMATED MULTI-PARAMETER HEMATOLOGYGKZ1985-09-17 View
510(k) K852372 CELL-DYN BRAND HEMATOLOGY REAGENTSJPK1985-09-03 View
510(k) K852373 AD150, AUTOMATED HEMATOLOGY DILUTORGKH1985-07-05 View
510(k) K845019 CELL-DYN 1000 AUTOMATED HEMATOLOGY ANALYZERGKL1985-03-26 View
510(k) K842786 DYNA-LYTE 2000CEM1984-09-14 View
510(k) K842446 DILU-MATIC 140GKH1984-09-06 View
510(k) K840170 CELL-DYN 100 WHOLE BLOOD PLATELETGKL1984-03-02 View
510(k) K832643 CELL-DYN 900 HEMATOLOGY ANALYZERGKL1983-09-26 View
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