Medical Device Manufacturer · US , Mountain View , CA

Abbott Diagnostics - FDA 510(k) Cleared Devices

28 submissions · 28 cleared · Since 1981
28
Total
28
Cleared
0
Denied
FDA 510(k) Regulatory Record - Abbott Diagnostics Hematology
20 devices
1-20 of 20
Cleared Oct 18, 1996
ABBOTT CELL-DYN 4000 SYSTEM
K961439 · GKZ
Hematology · 186d
Cleared Apr 18, 1989
CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER
K890491 · GKZ
Hematology · 77d
Cleared Apr 21, 1988
CELL-DYN RAPID-LYSE AND HEMOGLOBLIN
K881242 · GJZ
Hematology · 36d
Cleared Mar 31, 1988
CELL-DYN ISOTONIC DILUENT
K881130 · GIF
Hematology · 15d
Cleared Sep 09, 1987
CELL-DYN DIFF. SCREEN ISOTONIC DILUENT
K873347 · GIF
Hematology · 20d
Cleared Sep 09, 1987
CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.
K873348 · GGK
Hematology · 20d
Cleared Aug 06, 1987
CELL-DYN 610 HEMATOLOGY ANALYZER
K872761 · GKZ
Hematology · 24d
Cleared Mar 17, 1987
CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER
K870233 · GKZ
Hematology · 55d
Cleared Jan 01, 1986
CELL-DYN 1500 MULTI-PARAMETER HEMATOLOGY ANALYZER
K854368 · GKZ
Hematology · 64d
Cleared Sep 17, 1985
CELL-DYN 2000 AUTOMATED MULTI-PARAMETER HEMATOLOGY
K852371 · GKZ
Hematology · 105d
Cleared Sep 03, 1985
CELL-DYN BRAND HEMATOLOGY REAGENTS
K852372 · JPK
Hematology · 91d
Cleared Jul 05, 1985
AD150, AUTOMATED HEMATOLOGY DILUTOR
K852373 · GKH
Hematology · 31d
Cleared Mar 26, 1985
CELL-DYN 1000 AUTOMATED HEMATOLOGY ANALYZER
K845019 · GKL
Hematology · 89d
Cleared Sep 06, 1984
DILU-MATIC 140
K842446 · GKH
Hematology · 77d
Cleared Mar 02, 1984
CELL-DYN 100 WHOLE BLOOD PLATELET
K840170 · GKL
Hematology · 43d
Cleared Sep 26, 1983
CELL-DYN 900 HEMATOLOGY ANALYZER
K832643 · GKL
Hematology · 53d
Cleared Jul 18, 1983
CELL-DYN 400 HEMOTOLOGY ANALYZER
K831368 · GKL
Hematology · 83d
Cleared Jul 18, 1983
CELL-DYN 300 HEMATOLOGY ANALYZER
K832038 · GKL
Hematology · 24d
Cleared Dec 28, 1982
HEMATOLOGY ANALYZER
K823344 · GKL
Hematology · 50d
Cleared Jun 09, 1981
CELL DYN 800 HEMATOLOGY ANALYZER
K803218 · GKL
Hematology · 173d
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