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3201
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463
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725
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671
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535
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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,...
431
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Intervertebral Fusion Device...
403
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Mask, Surgical
400
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Screw, Fixation, Bone
386
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Manufacturers
US
ACON Laboratories, Inc.
Medical Device Manufacturer
·
US , San Diego , CA
ACON Laboratories, Inc. - FDA 510(k) Cleared Devices
85 submissions
·
85 cleared
·
Since 1998
Official Website
85
Total
85
Cleared
0
Denied
27
devices
26-27 of 27
Filters
1
2
Cleared
Jul 09, 2001
ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE
K010841
·
DIO
Toxicology
·
110d
Cleared
Mar 15, 2001
ACON THC ONE STEP MARIJUANA TEST STRIP(URINE)
K003557
·
LDJ
Toxicology
·
118d
1
2
Filters
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85
Chemistry
45
Toxicology
27
Microbiology
7
General Hospital
2
Immunology
1
General & Plastic Surgery
1
Hematology
1
Cardiovascular
1