FDA.report

510(k) K242820

Device
Puritan PurSafe Plus Collection and Transport System
Applicant
Puritan Medical Products, LLC
510(k) number
K242820
Product code
QBD
Decision
Substantially Equivalent (SESE)
Decision date
2025-05-27
Date received
2024-09-18
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
N

Related Records

Applicant Contact

Contact
Mehdi Karamchi
Address
31 School St., P.O. Box 149 Guilford ME US 04443 04443

FDA Registration Numbers

Source Documents

510(k) summary PDF

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