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Multichem Creatinine Reagent S0917

FDA 510(k)

Class II (US FDA 510(k))

510(k) K873725

by Simmler, Inc.

Identifiers

510(k) Number
K873725 FDA 510(k)
FDA Product Code
CGX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1225 FDA 510(k)
Regulation Number
862.1225 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Multichem Creatinine Reagent S0917 by Simmler, 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

Manufacturer
Simmler, Inc.

Sources (1)

  • FDA 510(k) K873725 24 fields · synced Jun 18, 2026