Device Classification Name |
Dna-Reagents, Neisseria
|
510(k) Number |
K132251 |
Device Name |
APTIMA COMBO 2 ASSAY (PANTHER SYSTEM) |
Applicant |
HOLOGIC / GEN-PROBE INCORPORATED |
10210 GENETIC CENTER DRIVE |
SAN DIEGO,
CA
92121 -4376
|
|
Correspondent |
HOLOGIC / GEN-PROBE INCORPORATED |
10210 GENETIC CENTER DRIVE |
SAN DIEGO,
CA
92121 -4376
|
|
Regulation Number | 866.3390
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/19/2013 |
Decision Date | 10/17/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Clinical Trials |
NCT01358799 NCT01733069
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|