COLONCARE


Device Classification Name

reagent, occult blood

510(k) Number K030216
Device Name COLONCARE
Original Applicant
CARE PRODUCTS, INC.
231 bank street
suite 203
waterbury, 
CT 
06702

Original Contact hubert pototschnig
Regulation Number 864.6550
Classification Product Code
KHE  
Date Received 01/21/2003
Decision Date 04/02/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No