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 Sera, Animal And Human
510(k) Number K861811
Device Name MOUSE SERUM - STERILE FILTERED
Applicant
Hazleton Research Products, Inc.
Box 7200
Denver,  PA  17517
Applicant Contact NOEL
Correspondent
Hazleton Research Products, Inc.
Box 7200
Denver,  PA  17517
Correspondent Contact NOEL
Regulation Number864.2800
Classification Product Code
KIS  
Date Received05/09/1986
Decision Date 05/20/1986
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
-
-