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Neopac Software, 3007 Digital Photometer/Fluorometer (Na +2 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K101392

by Astoria-Pacific, Inc.

Identifiers

510(k) Number
K101392 FDA 510(k)
FDA Product Code
KQP FDA 510(k)
Models / Variants
Na FDA 510(k)
307 FDA 510(k)
350d FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1315 FDA 510(k)
Regulation Number
862.1315 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Neopac Software, 3007 Digital Photometer/Fluorometer (Na +2 more) by Astoria-Pacific, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 3 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Astoria-Pacific, Inc.

Sources (1)

  • FDA 510(k) K101392 24 fields · synced Jun 18, 2026