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 Panels, Test, Susceptibility, Antimicrobial
510(k) Number K201423
Device Name MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)
Applicant
Beckman Coulter, Inc.
1584 Enterprise Blvd.
West Sacramento,  CA  95691
Applicant Contact Elaine Duncan
Correspondent
Beckman Coulter, Inc.
1584 Enterprise Blvd.
West Sacramento,  CA  95691
Correspondent Contact Elaine Duncan
Regulation Number866.1640
Classification Product Code
LTT  
Subsequent Product Codes
JWY   LRG   LTW  
Date Received05/29/2020
Decision Date 06/29/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-