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NATtrol BD MAX Vaginal Panel External Controls

FDA 510(k)

Class II (US FDA 510(k))

510(k) K201403

by Zeptometrix

Identifiers

510(k) Number
K201403 FDA 510(k)
FDA Product Code
PMN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.3920 FDA 510(k)
Regulation Number
866.3920 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

NATtrol BD MAX Vaginal Panel External Controls by Zeptometrix — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Zeptometrix

Sources (1)

  • FDA 510(k) K201403 24 fields · synced Jun 18, 2026