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510k Database
Manufacturers
US
Irvine Scientific
Medical Device Manufacturer
·
US , Mchenry , IL
Irvine Scientific - FDA 510(k) Cleared Devices
16 submissions
·
16 cleared
·
Since 1982
16
Total
16
Cleared
0
Denied
FDA 510(k) Regulatory Record - Irvine Scientific
Chemistry
✕
5
devices
1-5 of 5
Filters
Cleared
Jul 15, 1985
SPINAL FLUID CONTROL
K851820
·
JJY
Chemistry
·
80d
Cleared
Jul 13, 1982
LEVEL I LIPID CONTROL
K821559
·
JJY
Chemistry
·
49d
Cleared
Jul 13, 1982
LEVEL II LIPID CONTROL
K821560
·
JJY
Chemistry
·
49d
Cleared
Jul 08, 1982
LEVEL I CONTROL SERUM
K821557
·
JJY
Chemistry
·
44d
Cleared
Jul 02, 1982
LEVEL II CONTROL SERUM
K821558
·
JJX
Chemistry
·
38d
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Obstetrics & Gynecology
11
Chemistry
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