510k
Database
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Anesthesiology
332
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1064
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270
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806
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148
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623
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1322
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758
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99
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72
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1
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365
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579
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244
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155
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2054
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40
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309
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1582
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132
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Powered Laser Surgical Instrument
229
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211
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System, Imaging, Pulsed Doppler,...
208
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Automated Radiological Image...
205
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System, Image Processing,...
199
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Electrosurgical, Cutting &...
185
OLO
Orthopedic Stereotaxic Instrument
168
NHA
Abutment, Implant, Dental,...
156
MAX
Intervertebral Fusion Device...
138
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Thoracolumbosacral Pedicle Screw...
135
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Medical Laboratory Automation Systems, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Medical Laboratory Automation Systems, Inc. - FDA 510(k) Cleared Devi...
17 submissions
·
17 cleared
·
Since 1978
17
Total
17
Cleared
0
Denied
FDA 510(k) Regulatory Record - Medical Laboratory Automation Systems, Inc.
Microbiology
✕
4
devices
1-4 of 4
Filters
Cleared
Jan 18, 1991
GASTRO-INTESTINAL ACCU-CULSHURE TM
K903638
·
LIO
Microbiology
·
158d
Cleared
Oct 16, 1990
CHLAMYDIA ACCU-CULSHURE TM
K903405
·
LIO
Microbiology
·
77d
Cleared
Oct 16, 1990
VIRAL ACCU-CULSHURE TM
K903406
·
LIO
Microbiology
·
77d
Cleared
Jul 16, 1990
ANAEROBIC ACCU-CULSHURE(TM)
K901645
·
JTX
Microbiology
·
98d
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17
Hematology
10
Microbiology
4
Chemistry
2
Pathology
1