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 System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
510(k) Number K193103
Device Name NeoBase 2 Non-derivatized MSMS Kit
Applicant
Perkinelmer, Inc.
940 Winter St.
Waltham,  MA  02451
Applicant Contact Eva Nalian
Correspondent
Perkinelmer, Inc.
940 Winter St.
Waltham,  MA  02451
Correspondent Contact Eva Nalian
Regulation Number862.1055
Classification Product Code
NQL  
Date Received11/08/2019
Decision Date 02/07/2020
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
Predetermined Change
Control Plan Authorized		 No
-
-