← Back to catalogue

Von Willebrand Fac. Defic. Abnormal Control Plasma

FDA 510(k)

Class II (US FDA 510(k))

510(k) K860751

by Bio/Data Corp.

Identifiers

510(k) Number
K860751 FDA 510(k)
FDA Product Code
JPK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 864.8625 FDA 510(k)
Regulation Number
864.8625 FDA 510(k)
Advisory Committee
Hematology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Von Willebrand Fac. Defic. Abnormal Control Plasma by Bio/Data Corp. — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Bio/Data Corp.

Sources (1)

  • FDA 510(k) K860751 24 fields · synced Jun 18, 2026