Atlas FDA

JBAIDS INFLUENZA A&B DETECTION KIT

FDA 510(k) clearance K111775 · decided 2011-09-13

Clearance details

K-number
K111775
Device name
JBAIDS INFLUENZA A&B DETECTION KIT
Applicant
U.S. Army Medical Material Development Acitvity
Decision
Substantially Equivalent
Date received
2011-06-23
Decision date
2011-09-13
Days to decision
82 days
Clearance type
Traditional
Product code
OCC
Device class
2
Regulation number
866.3980
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Fort Detrick, MD, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.