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Accusign Doa 5 (thc +4 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K962353

by Princeton Biomeditech Corp.

Identifiers

510(k) Number
K962353 FDA 510(k)
FDA Product Code
DIO FDA 510(k)
Models / Variants
thc FDA 510(k)
Opi FDA 510(k)
Coc FDA 510(k)
Met Or Amp FDA 510(k)
Pcp 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)

Accusign Doa 5 (thc +4 more) by Princeton Biomeditech Corp. — Class II — FDA_510K — listed in FDA 510(k) — 5 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Princeton Biomeditech Corp.

Sources (1)

  • FDA 510(k) K962353 24 fields · synced Jun 18, 2026