Abbott Diagnostics

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
28
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K964185IMX CA 125November 4, 1997
K972182ABBOTT STREP A CONTROLSAugust 13, 1997
K961439ABBOTT CELL-DYN 4000 SYSTEMOctober 18, 1996
K890491CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYERApril 18, 1989
K881242CELL-DYN RAPID-LYSE AND HEMOGLOBLINApril 21, 1988
K881130CELL-DYN ISOTONIC DILUENTMarch 31, 1988
K873348CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.September 9, 1987
K873347CELL-DYN DIFF. SCREEN ISOTONIC DILUENTSeptember 9, 1987
K873408MODEL 690 SPECTROPHOTOMETERSeptember 8, 1987
K872761CELL-DYN 610 HEMATOLOGY ANALYZERAugust 6, 1987
K870233CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZERMarch 17, 1987
K854368CELL-DYN 1500 MULTI-PARAMETER HEMATOLOGY ANALYZERJanuary 1, 1986
K852371CELL-DYN 2000 AUTOMATED MULTI-PARAMETER HEMATOLOGYSeptember 17, 1985
K852372CELL-DYN BRAND HEMATOLOGY REAGENTSSeptember 3, 1985
K852373AD150, AUTOMATED HEMATOLOGY DILUTORJuly 5, 1985
K845019CELL-DYN 1000 AUTOMATED HEMATOLOGY ANALYZERMarch 26, 1985
K842786DYNA-LYTE 2000September 14, 1984
K842446DILU-MATIC 140September 6, 1984
K840170CELL-DYN 100 WHOLE BLOOD PLATELETMarch 2, 1984
K832643CELL-DYN 900 HEMATOLOGY ANALYZERSeptember 26, 1983