Lyophilized Platelets 5371

• FDA 510(k) K840329 decided 5 Apr 1984 Active
• FDA GUDID UDI-DI M52553710 listed 7 Sep 2016 Listed

1. 5 Apr 1984 Cleared FDA 510(k) K840329
2. 7 Sep 2016 Listed FDA GUDID M52553710

Trade name

Lyophilized Platelets

Generic name

von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD, reagent

Model / reference

5371

Primary DI / UDI-DI

M52553710

510(k) Number

K840329 ↗

FDA product code

GGP

GMDN term

von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD, reagent

Device class

Class II

Regulation number

864.7290

GUDID distribution status

In Commercial Distribution

Category: von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD, reagent

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