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1954
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1548
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1432
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510k Database
Manufacturers
US
Genzyme Corp.
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Medical Device Manufacturer
·
US , Cambridge , MA
Genzyme Corp. - FDA 510(k) Cleared Devices
27 submissions
·
27 cleared
·
Since 1991
View 27 510(k) Devices ↓
Official Website
27
Total
27
Cleared
0
Denied
27
devices
26-27 of 27
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1
2
Cleared
Jul 01, 1991
AMYLASE REAGENT
K912519
·
JFJ
Chemistry
·
25d
Cleared
May 22, 1991
HDL CHOLESTEROL REAGENT
K911406
·
LBR
Chemistry
·
54d
1
2
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27
Chemistry
17
Hematology
3
General & Plastic Surgery
3
Microbiology
3
Ear, Nose, Throat
1