ACCUMETER H. PYLORI TEST


Device Classification Name

helicobacter pylori

510(k) Number K960478
Device Name ACCUMETER H. PYLORI TEST
Applicant
CHEMTRAK, INC.
929 e. arques ave.
sunnyvale, 
CA 
94086

Applicant Contact rodger j richael
Correspondent
CHEMTRAK, INC.
929 e. arques ave.
sunnyvale, 
CA 
94086

Correspodent Contact rodger j richael
Regulation Number 866.3110
Classification Product Code
LYR  
Date Received 02/02/1996
Decision Date 06/27/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized