PrimeStore MTM— 510(k) DEN170029

Unknown

Longhorn Vaccines and Diagnostics, LLC

FDA 510(k) clearance DEN170029 for PrimeStore MTM, Unknown on 2018-03-19. Applicant: Longhorn Vaccines and Diagnostics, LLC. Device class: 2.

Clearance details

Applicant: Longhorn Vaccines and Diagnostics, LLC
Product code: Code QBD
Device class: Class 2
Regulation: 21 CFR 866.2950
Advisory panel: Microbiology
Date received: 2017-05-24
Decision date: 2018-03-19
Decision: Unknown
Clearance type: Direct
Location: Bethesda, MD, US

View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.