HEMOCCULT ICT


Device Classification Name

reagent, occult blood

510(k) Number K080812
Device Name HEMOCCULT ICT
Applicant
BECKMAN COULTER, INC.
200 south kraemer blvd. w-110
po box 8000
brea, 
CA 
92822

Applicant Contact sylvia zorich
Correspondent
BECKMAN COULTER, INC.
200 south kraemer blvd. w-110
po box 8000
brea, 
CA 
92822

Correspodent Contact sylvia zorich
Regulation Number 864.6550
Classification Product Code
KHE  
Date Received 03/24/2008
Decision Date 06/25/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls