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 Stains, Chemical Solution
510(k) Number K854176
Device Name POLYCHROME IV STAIN
Applicant
Devetec, Inc.
P.O. Box 10275
Bradenton,  FL  34282 -0275
Applicant Contact DONALD L PRICE
Correspondent
Devetec, Inc.
P.O. Box 10275
Bradenton,  FL  34282 -0275
Correspondent Contact DONALD L PRICE
Regulation Number864.1850
Classification Product Code
LED  
Date Received10/15/1985
Decision Date 10/31/1985
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
-
-