510(k) K062368

Device

WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401

Applicant

WAKO CHEMICALS, USA, INC.

510(k) number

K062368

Product code

OAU  

Decision

Substantially Equivalent (SESE)

Decision date

2007-01-31

Date received

2006-08-14

Regulation

866.6030

Classification name

Des-gamma-carboxy-prothrombin (dcp), Risk Assessment, Hepatocellular Carcinoma

Medical specialty

Immunology

Review panel

Immunology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No