• 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 enzymatic methods, galactose
510(k) Number K190335
Device Name GSP Neonatal Total Galactose kit
PerkinElmer Inc.
940 Winter Street
waltham,  MA  02451
Applicant Contact brian ciccariello
PerkinElmer Inc.
940 Winter Street
waltham,  MA  02451
Correspondent Contact brian ciccariello
Regulation Number862.1310
Classification Product Code
Date Received02/14/2019
Decision Date 11/06/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No