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 K893895
Device Name HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL
Applicant
Intercare Diagnostics, Inc.
P.O. Box 24124
Baltimore,  MD  21227
Applicant Contact EDUARDO UGARTE
Correspondent
Intercare Diagnostics, Inc.
P.O. Box 24124
Baltimore,  MD  21227
Correspondent Contact EDUARDO UGARTE
Regulation Number864.8625
Classification Product Code
JPK  
Date Received05/30/1989
Decision Date 07/25/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-