APTIMA COMBO 2 ASSAY


Device Classification Name

dna-reagents, neisseria

510(k) Number K111409
Device Name APTIMA COMBO 2 ASSAY
Applicant
GEN-PROBE, INC.
10210 genetic center dr.
san diego, 
CA 
92121 -4362

Applicant Contact jody j fleming
Correspondent
GEN-PROBE, INC.
10210 genetic center dr.
san diego, 
CA 
92121 -4362

Correspodent Contact jody j fleming
Regulation Number 866.3390
Classification Product Code
LSL  
Subsequent Product Codes
MKZ   NSU  
Date Received 05/19/2011
Decision Date 05/03/2012
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