Device Classification Name |
Mycoplasma Pneumoniae Dna Assay System
|
510(k) Number |
K152800 |
Device Name |
illumigene Mycoplasma DNA Amplification Assay |
Applicant |
MERIDIAN BIOSCIENCE, INC. |
3471 RIVER HILLS DRIVE |
CINCINNATI,
OH
45244
|
|
Applicant Contact |
Stefanie Johns |
Correspondent |
MERIDIAN BIOSCIENCE, INC. |
3471 RIVER HILLS DRIVE |
CINCINNATI,
OH
45244
|
|
Correspondent Contact |
Stefanie Johns |
Regulation Number | 866.3980
|
Classification Product Code |
|
Date Received | 09/28/2015 |
Decision Date | 10/23/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|