MODIFICATION TO: ACCUSIGN RC DOA 10 - Mtd

FDA 510(k)

Class II (US FDA 510(k))

510(k) K062575

Identifiers

510(k) Number: K062575 FDA 510(k)
FDA Product Code: LAG FDA 510(k)
Models / Variants: met FDA 510(k)
Opi FDA 510(k)
Coc FDA 510(k)
Thc FDA 510(k)
Pcp FDA 510(k)
Bzo FDA 510(k)
Bar FDA 510(k)
Mtd FDA 510(k)
Tca FDA 510(k)
Amp FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 862.3610 FDA 510(k)
Regulation Number: 862.3610 FDA 510(k)
Advisory Committee: Clinical Toxicology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

MODIFICATION TO: ACCUSIGN RC DOA 10 - Mtd by Princeton Biomeditech Corp. — Class II — FDA_510K — listed in FDA 510(k) — 10 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K062575	Class II	Active

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Manufacturer

Manufacturer: Princeton Biomeditech Corp.

Sources (1)

FDA 510(k) K062575 24 fields · synced Jun 18, 2026