EZ-HBT HELICOBACTER BLOOD TEST


Device Classification Name

test, urea (breath or blood)

510(k) Number K990931
Device Name EZ-HBT HELICOBACTER BLOOD TEST
Applicant
METABOLIC SOLUTIONS, INC.
460 amherst st.
nashua, 
NH 
03063 -1220

Applicant Contact david a wagner
Correspondent
METABOLIC SOLUTIONS, INC.
460 amherst st.
nashua, 
NH 
03063 -1220

Correspodent Contact david a wagner
Regulation Number 866.3110
Classification Product Code
MSQ  
Date Received 03/19/1999
Decision Date 09/24/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No