EASE-A-CULT


Device Classification Name

reagent, occult blood

510(k) Number K002756
Device Name EASE-A-CULT
Original Applicant
DIAGNOSTICA, INC.
p.o. box 4341
crofton, 
MD 
21114

Original Contact yolanda smith
Regulation Number 864.6550
Classification Product Code
KHE  
Date Received 09/05/2000
Decision Date 02/23/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

Type Traditional
Reviewed by Third Party No

Combination Product

No