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 Detectors, Electrochemical, Liquid Chromatography
510(k) Number K903231
Device Name COULOCHEM II
Applicant
Esa, Inc.
45 Wiggins Ave.
Bedford,  MA  01730
Applicant Contact PRENTISS C HIGGINS
Correspondent
Esa, Inc.
45 Wiggins Ave.
Bedford,  MA  01730
Correspondent Contact PRENTISS C HIGGINS
Regulation Number862.2260
Classification Product Code
LEQ  
Date Received07/23/1990
Decision Date 09/27/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-