• 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, blood culturing
510(k) Number K183166
Device Name BacT/ALERT FA Plus; BacT/ALERT PF Plus
Applicant
bioMerieux, Inc.
595 Anglum Road
Hazelwood,  MO  63042
Applicant Contact Mary Beth Anheuser
Correspondent
bioMerieux, Inc.
595 Anglum Road
Hazelwood,  MO  63042
Correspondent Contact Mary Beth Anheuser
Regulation Number866.2560
Classification Product Code
MDB  
Date Received11/15/2018
Decision Date 02/11/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-