Atlas FDA

PrimeStore MTM

FDA 510(k) clearance DEN170029 · decided 2018-03-19

Clearance details

K-number
DEN170029
Device name
PrimeStore MTM
Applicant
Longhorn Vaccines and Diagnostics, LLC
Decision
Unknown
Date received
2017-05-24
Decision date
2018-03-19
Days to decision
299 days
Clearance type
Direct
Product code
QBD
Device class
2
Regulation number
866.2950
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Bethesda, MD, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.