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 Enzymatic Esterase--Oxidase, Cholesterol
510(k) Number K864159
Device Name SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD
Applicant
Chem-Elec, Inc.
P.O. Box 372
North Webster,  IN  46555
Applicant Contact STEPHEN J JONES
Correspondent
Chem-Elec, Inc.
P.O. Box 372
North Webster,  IN  46555
Correspondent Contact STEPHEN J JONES
Regulation Number862.1175
Classification Product Code
CHH  
Date Received10/23/1986
Decision Date 06/10/1988
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
-
-