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 Hematoxylin Harris'S
510(k) Number K872498
Device Name HARRIS HEMATOXYLIN
Applicant
Anatech, Ltd.
1020 Harts Lake Rd.
Battle Creek,  MI  49015
Applicant Contact ADA T FELDMAN
Correspondent
Anatech, Ltd.
1020 Harts Lake Rd.
Battle Creek,  MI  49015
Correspondent Contact ADA T FELDMAN
Regulation Number864.1850
Classification Product Code
HYK  
Date Received06/24/1987
Decision Date 07/09/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-