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 Enzyme Immunoassay, Diphenylhydantoin
510(k) Number K963840
Device Name CEDIA PHENYTOIN II ASSAY
Applicant
Boehringer Mannheim Corp.
2400 Bisso Ln.
Concord,  CA  94524
Applicant Contact Yvette Lloyd
Correspondent
Boehringer Mannheim Corp.
2400 Bisso Ln.
Concord,  CA  94524
Correspondent Contact Yvette Lloyd
Regulation Number862.3350
Classification Product Code
DIP  
Subsequent Product Code
EIA  
Date Received09/24/1996
Decision Date 11/20/1996
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
-
-