S-TEST CA


Device Classification Name

azo dye, calcium

510(k) Number K072356
Device Name S-TEST CA
Applicant
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
4 henderson drive
west caldwell, 
NJ 
07006

Applicant Contact david slavin
Correspondent
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
4 henderson drive
west caldwell, 
NJ 
07006

Correspodent Contact david slavin
Regulation Number 862.1145
Classification Product Code
CJY  
Date Received 08/22/2007
Decision Date 06/24/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No