SAS BLOOD/SERUM/URINE/URINE HCG


Device Classification Name

visual, pregnancy hcg, prescription use

510(k) Number K022683
Device Name SAS BLOOD/SERUM/URINE/URINE HCG
Original Applicant
SA SCIENTIFIC, INC.
4919 golden quail
san antonio, 
TX 
78240

Original Contact ricardo r martinez
Regulation Number 862.1155
Classification Product Code
JHI  
Date Received 08/12/2002
Decision Date 12/16/2002
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