Device Classification Name |
dna-reagents, neisseria
|
510(k) Number |
K043224 |
Device Name |
GEN-PROBE APTIMA COMBO 2 ASSAY |
Applicant |
GEN-PROBE, INC. |
10210 GENETIC CENTER DR. |
SAN DIEGO,
CA
92121 -4362
|
|
Applicant Contact |
ALAN MADERAZO |
Correspondent |
GEN-PROBE, INC. |
10210 GENETIC CENTER DR. |
SAN DIEGO,
CA
92121 -4362
|
|
Correspondent Contact |
ALAN MADERAZO |
Regulation Number | 866.3390
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/22/2004 |
Decision Date | 08/09/2005 |
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
|
|
|