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 Activated Partial Thromboplastin
510(k) Number K972831
Device Name HEMOCHRON CITRATE APTT
Applicant
International Technidyne Corp.
8 Olsen Ave.
Edison,  NJ  08820
Applicant Contact ROBERT H MATLAND
Correspondent
International Technidyne Corp.
8 Olsen Ave.
Edison,  NJ  08820
Correspondent Contact ROBERT H MATLAND
Regulation Number864.7925
Classification Product Code
GFO  
Subsequent Product Code
JPA  
Date Received07/30/1997
Decision Date 11/20/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-