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533
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519
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489
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403
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400
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386
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Manufacturers
US
Seradyn, Inc.
Medical Device Manufacturer
·
US , Indianapolis , IN
Seradyn, Inc. - FDA 510(k) Cleared Devices
28 submissions
·
28 cleared
·
Since 1988
28
Total
28
Cleared
0
Denied
28
devices
26-28 of 28
Filters
1
2
Cleared
May 24, 1990
QUICK CHEM II
K901695
·
JJQ
Chemistry
·
44d
Cleared
Mar 28, 1989
QMS(TM) - THEOPHYLLINE
K885263
·
JQX
Chemistry
·
95d
Cleared
Jan 05, 1988
REAGENT A AND REAGENT B
K874413
·
JIX
Chemistry
·
69d
1
2
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28
Chemistry
15
Toxicology
9
Microbiology
2
Immunology
2