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Manufacturers
US
Helmer Labs, Inc.
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Medical Device Manufacturer
·
US , Mchenry , IL
Helmer Labs, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1977
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Helmer Labs, Inc.
Hematology
✕
3
devices
1-3 of 3
Filters
Cleared
Sep 29, 1981
PLATELET AGITATOR
K812533
·
KSQ
Hematology
·
27d
Cleared
Dec 11, 1980
HEMATIC BLOOD MIXER
K802608
·
KSQ
Hematology
·
51d
Cleared
Jul 11, 1977
PLATELET AGITATOR
K770830
·
GLE
Hematology
·
66d
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3
Hematology
3