|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
pda699/pda700 protamine dose assay for hep. neutra
|
INTERNATIONAL TECHNIDYNE CORP.
|
K870831 |
06/01/1987
|
itc microsample coagulation analyzer system
|
INTERNATIONAL TECHNIDYNE CORP.
|
K923761 |
01/21/1993
|
jr. microcoagulation system
|
INTERNATIONAL TECHNIDYNE CORP.
|
K940401 |
05/11/1994
|
hemochron verigy system/factor vi qualify system
|
INTERNATIONAL TECHNIDYNE CORP.
|
K940957 |
10/18/1994
|
hemochron citrate aptt
|
INTERNATIONAL TECHNIDYNE CORP.
|
K972831 |
11/20/1997
|
hemochron jr generation ii, hemochron jr signature
|
INTERNATIONAL TECHNIDYNE CORP.
|
K974799 |
07/07/1998
|
hemochron electronic system verification tube
|
INTERNATIONAL TECHNIDYNE CORP.
|
K990449 |
04/13/1999
|
hemochron response
|
INTERNATIONAL TECHNIDYNE CORP.
|
K983475 |
05/03/1999
|
hemochron jr. signature +
|
INTERNATIONAL TECHNIDYNE CORP.
|
K020798 |
03/28/2002
|
hemochron response/system
|
INTERNATIONAL TECHNIDYNE CORP.
|
K030818 |
04/02/2003
|