• 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 | Inspections
 


New Search Back To Search Results
Device Classification Name plasma, coagulation control
510(k) Number K120977
Device Name DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC
Applicant
INTERNATIONAL TECHNIDYNE CORP.
23 nevsky st.
edison,  NJ  08820
Applicant Contact lawrence picciano
Correspondent
INTERNATIONAL TECHNIDYNE CORP.
23 nevsky st.
edison,  NJ  08820
Correspodent Contact lawrence picciano
Regulation Number864.5425
Classification Product Code
GGN  
Date Received04/02/2012
Decision Date 07/03/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-