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 system, multipurpose for in vitro coagulation studies
510(k) Number K990449
Device Name HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE
Applicant
INTERNATIONAL TECHNIDYNE CORP.
6 OLSEN AVE.
EDISON,  NJ  08820
Applicant Contact JOHN CLAY
Correspondent
INTERNATIONAL TECHNIDYNE CORP.
6 OLSEN AVE.
EDISON,  NJ  08820
Correspondent Contact JOHN CLAY
Regulation Number864.5425
Classification Product Code
JPA  
Date Received02/12/1999
Decision Date 04/13/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-