QUICKVUE ONE-STEP H. PYLORI II TEST


Device Classification Name

helicobacter pylori

510(k) Number K991747
Device Name QUICKVUE ONE-STEP H. PYLORI II TEST
Applicant
QUIDEL CORP.
10165 mckellar ct.
san diego, 
CA 
92121

Applicant Contact robin weiner
Correspondent
QUIDEL CORP.
10165 mckellar ct.
san diego, 
CA 
92121

Correspodent Contact robin weiner
Regulation Number 866.3110
Classification Product Code
LYR  
Date Received 05/21/1999
Decision Date 08/04/1999
Decision

substantially equivalent

(SESE)
Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology
summary

summary

Type Traditional
Reviewed by Third Party No
Combination Product

No