510(k) K233324

Device
Molecular Transport Media - MTM
Applicant
Alb Luz
510(k) number
K233324
Product code
QBD
Decision
Substantially Equivalent (SESE)
Decision date
2024-06-17
Date received
2023-09-29
Regulation
866.2950
Classification name
Microbial Nucleic Acid Storage And Stabilization Device
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Ana Luiza Bueno Luz
Address
Rua Um, 437 Valinhos BR 13273-200 13273-200

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
07898996204655Molecular Transport Media (MTM) 3mlA. L. B. LUZ2024-08-29
07898996204648Molecular Transport Media (MTM) 2mlA. L. B. LUZ2024-08-29

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