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 Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
510(k) Number K071316
Device Name MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPTOMYCIN SYNERGY SCREEN
Applicant
Dade Behring, Inc.
2040 Enterprise Blvd.
West Sacramento,  CA  95691
Applicant Contact ROBERT EUSEBIO
Correspondent
Dade Behring, Inc.
2040 Enterprise Blvd.
West Sacramento,  CA  95691
Correspondent Contact ROBERT EUSEBIO
Regulation Number866.1640
Classification Product Code
LRG  
Subsequent Product Codes
JWY   LTT  
Date Received05/10/2007
Decision Date 08/20/2007
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
Predetermined Change
Control Plan Authorized		 No
-
-