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NeoBase 2 Non-derivatized MSMS Kit

FDA 510(k)

Class II (US FDA 510(k))

510(k) K193103

by Perkinelmer, Inc.

Identifiers

510(k) Number
K193103 FDA 510(k)
FDA Product Code
NQL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1055 FDA 510(k)
Regulation Number
862.1055 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

NeoBase 2 Non-derivatized MSMS Kit by Perkinelmer, 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
Perkinelmer, Inc.

Sources (1)

  • FDA 510(k) K193103 24 fields · synced Jun 18, 2026