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Drugcheck X Multidrug Screening Device

FDA 510(k)

Class II (US FDA 510(k))

510(k) K992748

by Syntron Bioresearch, Inc.

Identifiers

510(k) Number
K992748 FDA 510(k)
FDA Product Code
DIO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.3250 FDA 510(k)
Regulation Number
862.3250 FDA 510(k)
Advisory Committee
Clinical Toxicology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Drugcheck X Multidrug Screening Device by Syntron Bioresearch, Inc. — 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

Sources (1)

  • FDA 510(k) K992748 24 fields · synced Jun 18, 2026