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Manufacturers
US
Iquum, Inc.
Medical Device Manufacturer
·
US , Marlborough , MA
Iquum, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2011
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Iquum, Inc.
Microbiology
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 25, 2016
cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System
K153544
·
OCC
Microbiology
·
227d
Cleared
Nov 04, 2014
LIAT STREP A ASSAY
K141338
·
PGX
Microbiology
·
167d
Cleared
Aug 04, 2011
LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER
K111387
·
OCC
Microbiology
·
79d
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3
Microbiology
3