Device Classification Name |
Kit, Identification, Enterobacteriaceae
|
510(k) Number |
K150031 |
Device Name |
hemoFISH Masterpanel |
Applicant |
MIACOM DIAGNOSTICS GMBH |
MEROWINGERPLATZ 1A |
DUSSELDORF,
DE
40225
|
|
Applicant Contact |
EVE BLOMEKE |
Correspondent |
MIACOM DIAGNOSTICS GMBH |
MEROWINGERPLATZ 1A |
DUSSELDORF,
DE
40225
|
|
Correspondent Contact |
EVE BLOMEKE |
Regulation Number | 866.2660
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/08/2015 |
Decision Date | 10/01/2015 |
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
|
|
|