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4312
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3201
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2736
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464
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2287
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3885
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3553
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774
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1404
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851
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492
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958
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4597
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System, Image Processing,...
725
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688
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549
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System, Imaging, Pulsed Doppler,...
533
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Powered Laser Surgical Instrument
519
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Polymer Patient Examination Glove
489
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Prosthesis, Knee,...
448
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Intervertebral Fusion Device...
403
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Mask, Surgical
400
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Screw, Fixation, Bone
388
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Manufacturers
US
Abbott Diagnostics
Medical Device Manufacturer
·
US , Mountain View , CA
Abbott Diagnostics - FDA 510(k) Cleared Devices
28 submissions
·
28 cleared
·
Since 1981
Official Website
28
Total
28
Cleared
0
Denied
28
devices
26-28 of 28
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1
2
Cleared
Oct 08, 1982
MODEL 340 SPECTROPHOTOMETER
K822720
·
JJQ
Chemistry
·
31d
Cleared
Jun 09, 1981
CELL DYN 800 HEMATOLOGY ANALYZER
K803218
·
GKL
Hematology
·
173d
Cleared
Feb 10, 1981
MODEL AM 721 ELECTROLYTE ANALYZER
K810135
·
JGS
Chemistry
·
20d
1
2
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28
Hematology
20
Chemistry
4
Toxicology
2
Immunology
1
Microbiology
1