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Pico (30 +2 more) - 50

FDA 510(k)

Class II (US FDA 510(k))

510(k) K962158

by Radiometer America, Inc.

Identifiers

510(k) Number: K962158 FDA 510(k)
FDA Product Code: JKA FDA 510(k)
Models / Variants: 30 FDA 510(k)
50 FDA 510(k)
70 FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 862.1675 FDA 510(k)
Regulation Number: 862.1675 FDA 510(k)
Advisory Committee: Clinical Chemistry FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Pico (30 +2 more) - 50 by Radiometer America, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 3 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer: Radiometer America, Inc.

Sources (1)

FDA 510(k) K962158 24 fields · synced Jun 18, 2026