INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST


Device Classification Name

reagent, occult blood

510(k) Number K021423
Device Name INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST
Original Applicant
ALFA SCIENTIFIC DESIGNS, INC.
12330 stowe dr.
poway, 
CA 
92064

Original Contact naishu wang
Regulation Number 864.6550
Classification Product Code
KHE  
Date Received 05/03/2002
Decision Date 06/17/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No