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 Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
510(k) Number K850617
Device Name CORNING 780 FLUOROMETER/DENSITOMETER
Applicant
Corning Medical & Scientific
Corning Glass Works
Medfield,  MA  02052
Applicant Contact William J Pignato
Correspondent
Corning Medical & Scientific
Corning Glass Works
Medfield,  MA  02052
Correspondent Contact William J Pignato
Regulation Number862.2400
Classification Product Code
JQT  
Date Received02/15/1985
Decision Date 03/12/1985
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
-
-