Atlas FDA

Accula Flu A/Flu B Test

FDA 510(k) clearance K171641 · decided 2018-02-06

Clearance details

K-number
K171641
Device name
Accula Flu A/Flu B Test
Applicant
Mesa Biotech, Inc.
Decision
Substantially Equivalent
Date received
2017-06-02
Decision date
2018-02-06
Days to decision
249 days
Clearance type
Dual Track
Product code
OZE
Device class
2
Regulation number
866.3980
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
San Diego, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.