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 Cells, Animal And Human, Cultured
510(k) Number K962780
Device Name FRESHCELLS, HEP-2
Applicant
DIAGNOSTIC HYBRIDS, INC.
ONE PRESIDENT ST.
ATHENS,  OH  45701
Applicant Contact JAMES L BROWN
Correspondent
DIAGNOSTIC HYBRIDS, INC.
ONE PRESIDENT ST.
ATHENS,  OH  45701
Correspondent Contact JAMES L BROWN
Regulation Number864.2280
Classification Product Code
KIR  
Date Received07/17/1996
Decision Date 08/29/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-