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510k Database
Manufacturers
US
Roche Diagnostics
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Medical Device Manufacturer
·
US , Indianapolos , IN
Roche Diagnostics - FDA 510(k) Cleared Devices
184 submissions
·
182 cleared
·
Since 2005
Official Website
184
Total
182
Cleared
2
Denied
27
devices
26-27 of 27
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1
2
Cleared
May 05, 2009
ELECSYS RUBELLA IGG CALCHECK
K090311
·
JJX
Microbiology
·
88d
Cleared
Feb 12, 2009
ELECSYS TOXO IGG CALCHECK
K083655
·
JJX
Microbiology
·
64d
1
2
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184
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117
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27
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25
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8
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5
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2