QUIDEL MOLECULAR HMPV ASSAY


Device Classification Name

human metapneumovirus (hmpv) rna assay system

510(k) Number K112490
Device Name QUIDEL MOLECULAR 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  
Date Received 08/29/2011
Decision Date 12/15/2011
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