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 nucleic acid amplification, novel influenza a virus, a/h5 (asian lineage) rna
510(k) Number K080570
Device Name CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANEL
Applicant
CENTERS FOR DISEASE CONTROL AND PREVENTION
1600 CLIFTON RD.,MS-C12
ATLANTA,  GA  30333
Applicant Contact STEPHEN LINDSTROM
Correspondent
CENTERS FOR DISEASE CONTROL AND PREVENTION
1600 CLIFTON RD.,MS-C12
ATLANTA,  GA  30333
Correspondent Contact STEPHEN LINDSTROM
Regulation Number866.3332
Classification Product Code
NXD  
Date Received02/29/2008
Decision Date 09/30/2008
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
-
-