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 Colorimeter, Photometer, Spectrophotometer For Clinical Use
510(k) Number K884124
Device Name AUTOMATED EIA READER MODEL EL311
Applicant
Bio-Tek Instruments, Inc.
Hihgland Park
Box 998
Winooski,  VT  05404
Applicant Contact DAN CONTOIS
Correspondent
Bio-Tek Instruments, Inc.
Hihgland Park
Box 998
Winooski,  VT  05404
Correspondent Contact DAN CONTOIS
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received09/30/1988
Decision Date 01/03/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-