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 Dna-Probe, Staphylococcus Aureus
510(k) Number K902213
Device Name ACCUPROBE STAPHYLOCOCCUS AUREUS CULTURE CONFIRMA.
Applicant
Gen-Probe, Inc.
9880 Campus Point Dr.
San Diego,  CA  92121
Applicant Contact CONNIE KIRBY
Correspondent
Gen-Probe, Inc.
9880 Campus Point Dr.
San Diego,  CA  92121
Correspondent Contact CONNIE KIRBY
Regulation Number866.3700
Classification Product Code
MCS  
Date Received05/16/1990
Decision Date 08/06/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-