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 K842092
Device Name SERALYZER ARIS PHENYTOIN REAGENT STRIPS
Applicant
Miles Laboratories, Inc.
P.O. Box 40
Elkhart,  IN  46515
Applicant Contact H ENGELMANN
Correspondent
Miles Laboratories, Inc.
P.O. Box 40
Elkhart,  IN  46515
Correspondent Contact H ENGELMANN
Regulation Number862.3350
Classification Product Code
DIP  
Date Received05/24/1984
Decision Date 03/19/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-