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 Calibrators, Drug Mixture
510(k) Number K980853
Device Name CEDIA DAU MULTI-DRUG CALIBRATORS
Applicant
Boehringer Mannheim Corp.
4300 Hacienda Dr.
Pleasanton,  CA  94588
Applicant Contact BETSY SOARES-MADDOX
Correspondent
Boehringer Mannheim Corp.
4300 Hacienda Dr.
Pleasanton,  CA  94588
Correspondent Contact BETSY SOARES-MADDOX
Regulation Number862.3200
Classification Product Code
DKB  
Date Received03/05/1998
Decision Date 04/21/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-