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519
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502
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483
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403
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395
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350
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347
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Manufacturers
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Genzyme Corporation
Medical Device Manufacturer
·
US , Cambridge , MA
Genzyme Corporation - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 2005
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Genzyme Corporation
Chemistry
✕
1
devices
1-1 of 1
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Cleared
May 15, 2008
GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR
K080662
·
NDY
Chemistry
·
66d
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6
Microbiology
2
General & Plastic Surgery
2
Ear, Nose, Throat
1
Chemistry
1