QUIDEL MOLECULAR RSV + HMPV ASSAY


Device Classification Name

human metapneumovirus (hmpv) rna assay system

510(k) Number K122189
Device Name QUIDEL MOLECULAR RSV + HMPV ASSAY
Applicant
QUIDEL CORP.
10165 mckellar ct.
san diego, 
CA 
92121

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

Correspodent Contact ronald h lollar
Regulation Number 866.3980
Classification Product Code
OEM  
Subsequent Product Code
OCC  
Date Received 07/24/2012
Decision Date 03/08/2013
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