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 Mixture, Hematology Quality Control
510(k) Number K053362
Device Name CELL-CHEX AUTO
Applicant
Streck
7002 S. 109th St.
La Vista,  NE  68128
Applicant Contact KERRIE OETTER
Correspondent
Streck
7002 S. 109th St.
La Vista,  NE  68128
Correspondent Contact KERRIE OETTER
Regulation Number864.8625
Classification Product Code
JPK  
Date Received12/02/2005
Decision Date 01/13/2006
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
Predetermined Change
Control Plan Authorized		 No
-
-