Atlas FDA

XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FAST

FDA 510(k) clearance K103776 · decided 2011-07-01

Clearance details

K-number
K103776
Device name
XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FAST
Applicant
Luminex Molecular Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2010-12-27
Decision date
2011-07-01
Days to decision
186 days
Clearance type
Traditional
Product code
OCC
Device class
2
Regulation number
866.3980
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Toronto, Ontario, CA
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.