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 Plasma, Control, Normal
510(k) Number K932145
Device Name COAGULATION REFERENCE PLASMA, NORMAL
Applicant
American Diagnostic Corp.
222 Railroad Ave.
P.O. Box 1165
Greenwich,  CT  06836
Applicant Contact VINCENT FORTE
Correspondent
American Diagnostic Corp.
222 Railroad Ave.
P.O. Box 1165
Greenwich,  CT  06836
Correspondent Contact VINCENT FORTE
Regulation Number864.5425
Classification Product Code
GIZ  
Date Received05/04/1993
Decision Date 10/18/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-