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489
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403
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Manufacturers
US
Hyperion, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Hyperion, Inc. - FDA 510(k) Cleared Devices
8 submissions
·
8 cleared
·
Since 1984
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hyperion, Inc.
Chemistry
✕
5
devices
1-5 of 5
Filters
Cleared
Dec 09, 1994
MICROREADER 4
K935983
·
JJQ
Chemistry
·
360d
Cleared
Jan 15, 1992
HY-PREP SYSTEM
K913809
·
JQW
Chemistry
·
142d
Cleared
Sep 14, 1987
MICRO-READER II
K873138
·
JJQ
Chemistry
·
35d
Cleared
Nov 28, 1986
MICRO-READER
K864060
·
JJQ
Chemistry
·
39d
Cleared
Feb 11, 1986
COMPUTING SPECTROPHOTOMETER BIO-CHEMISTRY ANALYZER
K855149
·
JJQ
Chemistry
·
47d
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8
Chemistry
5
Immunology
2
General Hospital
1