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 Agent, Clearing
510(k) Number K881282
Device Name XYLENE
Applicant
Anatech, Ltd.
1020 Harts Lake Rd.
Battle Creek,  MI  49015
Applicant Contact FELDMAN, M.S.
Correspondent
Anatech, Ltd.
1020 Harts Lake Rd.
Battle Creek,  MI  49015
Correspondent Contact FELDMAN, M.S.
Regulation Number864.4010
Classification Product Code
KEM  
Date Received03/25/1988
Decision Date 04/05/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-