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 K904567
Device Name DYNATECH MR4000 MICROPLATE READER
Applicant
Dynatech Corp.
14340 Sullyfield Cir.
Chantilly,  VA  22021
Applicant Contact JOHN HOPE
Correspondent
Dynatech Corp.
14340 Sullyfield Cir.
Chantilly,  VA  22021
Correspondent Contact JOHN HOPE
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received10/09/1990
Decision Date 01/28/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-