Device Classification Name |
assayed external control material for microbiology nucleic acid amplification (nat) assays
|
510(k) Number |
K161573 |
Device Name |
FilmArray RP EZ Control Panel M265 |
Applicant |
MAINE MOLECULAR QUALITY CONTROLS, INC. |
23 MILL BROOK ROAD |
SACO,
ME
04072
|
|
Applicant Contact |
JOAN GORDON |
Correspondent |
MAINE MOLECULAR QUALITY CONTROLS, INC. |
23 MILL BROOK ROAD |
SACO,
ME
04072
|
|
Correspondent Contact |
JOAN GORDON |
Regulation Number | 866.3920
|
Classification Product Code |
|
Date Received | 06/07/2016 |
Decision Date | 09/02/2016 |
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
|
|
|