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 test, time, prothrombin
510(k) Number K010599
Device Name PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE
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 Number864.7750
Classification Product Code
GJS  
Date Received02/28/2001
Decision Date 07/02/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-