CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL


Device Classification Name

2009 h1n1 influenza virus (swine origin), nucleic acid or antigen, detection and identification

510(k) Number K111507
Device Name CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
Applicant
CENTERS FOR DISEASE CONTROL AND PREVENTION
1600 clifton rd. ms-c12
atlanta, 
GA 
30333

Applicant Contact capt hye-joo kim, pharm.d.
Correspondent
CENTERS FOR DISEASE CONTROL AND PREVENTION
1600 clifton rd. ms-c12
atlanta, 
GA 
30333

Correspodent Contact capt hye-joo kim, pharm.d.
Regulation Number 866.3332
Classification Product Code
OQW  
Subsequent Product Codes
NSU   NXD   OEP  
Date Received 06/01/2011
Decision Date 08/23/2011
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