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519
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489
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431
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403
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400
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386
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Manufacturers
US
Roche Molecular Systems, Inc.
Medical Device Manufacturer
·
US , Somerville , NJ
Roche Molecular Systems, Inc. - FDA 510(k) Cleared Devices
51 submissions
·
48 cleared
·
Since 1993
51
Total
48
Cleared
3
Denied
51
devices
51-51 of 51
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Cleared
Jun 15, 1993
AMPLICOR CHLAMYDIA TRACHOMATIS TEST
K922906
·
MKZ
Microbiology
·
363d
1
2
3
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51
Microbiology
45
Chemistry
4
Hematology
1
Radiology
1