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510k Database
Manufacturers
US
Labsystems, Inc.
Medical Device Manufacturer
·
US , Walker , MI
Labsystems, Inc. - FDA 510(k) Cleared Devices
17 submissions
·
17 cleared
·
Since 1984
17
Total
17
Cleared
0
Denied
FDA 510(k) Regulatory Record - Labsystems, Inc.
Immunology
✕
1
devices
1-1 of 1
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Cleared
Jan 08, 1986
CYTOMEGALOVIRUS IGG EIA TEST KIT
K843189
·
GQI
Immunology
·
513d
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17
Microbiology
11
Chemistry
3
Immunology
1
Hematology
1
Physical Medicine
1