GENZYME CONTRAST II HCG URINE/SERUM TEST


Device Classification Name

visual, pregnancy hcg, prescription use

510(k) Number K023544
Device Name GENZYME CONTRAST II HCG URINE/SERUM TEST
Original Applicant
GENZYME CORP.
one kendall square
cambridge, 
MA 
02139

Original Contact e.v. goorchenko
Regulation Number 862.1155
Classification Product Code
JHI  
Date Received 10/22/2002
Decision Date 01/16/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No