QUIDEL MOLECULAR INFLUENZA A + B ASSAY


Device Classification Name

respiratory virus panel nucleic acid assay system

510(k) Number K112172
Device Name QUIDEL MOLECULAR INFLUENZA A + B ASSAY
Applicant
QUIDEL CORP.
10165 mckellar ct.
san diego, 
CA 
92121

Applicant Contact ronald lollar
Correspondent
QUIDEL CORP.
10165 mckellar ct.
san diego, 
CA 
92121

Correspodent Contact ronald lollar
Regulation Number 866.3980
Classification Product Code
OCC  
Subsequent Product Code
OOI  
Date Received 07/28/2011
Decision Date 12/22/2011
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