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


Device Classification Name

system, test, fibrin/fibrinogen degradation products for monitoring of colorectal cancer

510(k) Number K072901
Device Name AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101
Applicant
AMDL, INC.
2492 walnut ave. suite 100
tustin, 
CA 
92780 -7039

Applicant Contact gary dreher
Correspondent
AMDL, INC.
2492 walnut ave. suite 100
tustin, 
CA 
92780 -7039

Correspodent Contact gary dreher
Regulation Number 866.6010
Classification Product Code
NTY  
Date Received 10/11/2007
Decision Date 07/01/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No