• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections

New Search Back To Search Results
Device Classification Name colorimeter, photometer, spectrophotometer for clinical use
510(k) Number K790422
Device Name MULTISKAN (78-503-00)
Original Applicant
Regulation Number862.2300
Classification Product Code
Date Received02/28/1979
Decision Date 04/20/1979
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No