Atlas FDA

INPLEX CF MOLECULAR TEST

FDA 510(k) clearance K063787 · decided 2008-03-13

Clearance details

K-number
K063787
Device name
INPLEX CF MOLECULAR TEST
Applicant
Third Wave Technologies, Inc.
Decision
Substantially Equivalent
Date received
2006-12-21
Decision date
2008-03-13
Days to decision
448 days
Clearance type
Traditional
Product code
NUA
Device class
2
Regulation number
866.5900
Medical specialty
Immunology
Advisory committee
Immunology
Location
Madison, WI, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.