CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANEL


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

Correspodent Contact stephen lindstrom
Regulation Number 866.3332
Classification Product Code
NXD  
Date Received 02/29/2008
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