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 Colorimetric Method, Triglycerides
510(k) Number K885134
Device Name CLINISTAT TRIGLYCERIDES REAGENT TEST
Applicant
Heraeus Kulzer, Inc.
Diagnostics Division
P.O. Box 70
Elkhart,  IN  46515
Applicant Contact ROSANNE M SAVOL
Correspondent
Heraeus Kulzer, Inc.
Diagnostics Division
P.O. Box 70
Elkhart,  IN  46515
Correspondent Contact ROSANNE M SAVOL
Regulation Number862.1705
Classification Product Code
JGY  
Date Received12/12/1988
Decision Date 02/10/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-