GENZYME OSOM TRICHOMONAS RAPID TEST

Device Classification Name

kit, screening, trichomonas

510(k) Number K033864
Device Name GENZYME OSOM TRICHOMONAS RAPID TEST
Applicant
GENZYME CORP.
one kendall square
cambridge, 
MA 
02139

Applicant Contact e.v. goorchenko
Correspondent
GENZYME CORP.
one kendall square
cambridge, 
MA 
02139

Correspodent Contact e.v. goorchenko
Regulation Number 866.2660
Classification Product Code
JWZ  
Date Received 12/12/2003
Decision Date 04/02/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No