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 Eosin Y
510(k) Number K893663
Device Name INSTANT EOSIN-AQUEOUS
Applicant
Shandon, Inc.
171 Industry Dr.
Pittsburgh,  PA  15275
Applicant Contact JANET CROOKHAM
Correspondent
Shandon, Inc.
171 Industry Dr.
Pittsburgh,  PA  15275
Correspondent Contact JANET CROOKHAM
Regulation Number864.1850
Classification Product Code
HYB  
Date Received05/15/1989
Decision Date 06/13/1989
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
-
-