Medical Device Manufacturer · US , Mountain View , CA

Abbott Diagnostics

28 submissions · 28 cleared · Since 1981
28
Total
28
Cleared
0
Denied

Abbott Diagnostics — FDA 510(k) Submissions

Abbott Diagnostics has submitted 28 FDA 510(k) premarket notifications since 1981, of which 28 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Counter, Cell, Automated (particle Counter), Counter, Differential Cell, Colorimeter, Photometer, Spectrophotometer For Clinical Use, Diluent, Blood Cell, Apparatus, Automated Blood Cell Diluting . Use the specialty filter in the sidebar to narrow results.

28 devices
1–12 of 28
IMX CA 125
K964185 · LTK Test, Epithelial Ovarian... · Immunology
Nov 1997 379d
ABBOTT STREP A CONTROLS
K972182 · MJZ Kit, Direct Antigen,... · Microbiology
Aug 1997 76d
ABBOTT CELL-DYN 4000 SYSTEM
K961439 · GKZ Counter, Differential Cell · Hematology
Oct 1996 186d
CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER
K890491 · GKZ Counter, Differential Cell · Hematology
Apr 1989 77d
CELL-DYN RAPID-LYSE AND HEMOGLOBLIN
K881242 · GJZ Cyanomethemoglobin... · Hematology
Apr 1988 36d
CELL-DYN ISOTONIC DILUENT
K881130 · GIF Diluent, Blood Cell · Hematology
Mar 1988 15d
CELL-DYN DIFF. SCREEN ISOTONIC DILUENT
K873347 · GIF Diluent, Blood Cell · Hematology
Sep 1987 20d
CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.
K873348 · GGK Products, Red-cell Lysing... · Hematology
Sep 1987 20d
MODEL 690 SPECTROPHOTOMETER
K873408 · JJQ Colorimeter, Photometer,... · Chemistry
Sep 1987 14d
CELL-DYN 610 HEMATOLOGY ANALYZER
K872761 · GKZ Counter, Differential Cell · Hematology
Aug 1987 24d
CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER
K870233 · GKZ Counter, Differential Cell · Hematology
Mar 1987 55d
CELL-DYN 1500 MULTI-PARAMETER HEMATOLOGY ANALYZER
K854368 · GKZ Counter, Differential Cell · Hematology
Jan 1986 64d
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