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 Ldl & Vldl Precipitation, Hdl
510(k) Number K874820
Device Name MULTICHEM HDL PRECIPITATING REAGENT #S0914
Applicant
Simmler, Inc.
Post Office Box 25179
St. Louis,  MO  63125
Applicant Contact CRIDER, PHD
Correspondent
Simmler, Inc.
Post Office Box 25179
St. Louis,  MO  63125
Correspondent Contact CRIDER, PHD
Regulation Number862.1475
Classification Product Code
LBR  
Date Received11/24/1987
Decision Date 01/07/1988
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
-
-