510(k) K072901

Device

AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101

Applicant

AMDL, INC.

510(k) number

K072901

Product code

NTY  

Decision

Substantially Equivalent (SESE)

Decision date

2008-07-01

Date received

2007-10-11

Regulation

866.6010

Classification name

System, Test, Fibrin/fibrinogen Degradation Products For Monitoring Of Colorectal Cancer

Medical specialty

Immunology

Review panel

Immunology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No