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, Ethyl Alcohol
510(k) Number K853532
Device Name ALCOHOL CALIBRATORS
Applicant
Diagnostic Systems
480 Democrat Rd.
Gibbstown,  NJ  08027
Applicant Contact RAYMOND L MILLER
Correspondent
Diagnostic Systems
480 Democrat Rd.
Gibbstown,  NJ  08027
Correspondent Contact RAYMOND L MILLER
Regulation Number862.3200
Classification Product Code
DNN  
Date Received08/23/1985
Decision Date 09/16/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-