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 Assay, Glycosylated Hemoglobin
510(k) Number K951361
Device Name DCA 2000 SYSTEM FOR HEMOGLOBIN A1C
Applicant
Heraeus Kulzer, Inc.
P.O. Box 2004
Mishawaka,  IN  46546 -2004
Applicant Contact ROSANNE M SAVOL
Correspondent
Heraeus Kulzer, Inc.
P.O. Box 2004
Mishawaka,  IN  46546 -2004
Correspondent Contact ROSANNE M SAVOL
Regulation Number864.7470
Classification Product Code
LCP  
Date Received03/27/1995
Decision Date 05/05/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-