Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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
Correspondent Contact SYLVIA ZORICH
Regulation Number864.6550
Classification Product Code
KHE  
Date Received03/24/2008
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
-
-