Device Classification Name |
System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
|
510(k) Number |
K142677 |
Device Name |
MALDI Biotyper CA System |
Applicant |
BRUKER DALTONICS, INC |
40 MANNING RD |
BILLERICA,
MA
01821
|
|
Applicant Contact |
Ken Hirakawa |
Correspondent |
BRUKER DALTONICS, INC |
Fahrenheilstrasse-4 |
Bremen,
DE
28359
|
|
Correspondent Contact |
Markus Kostrzewa |
Regulation Number | 866.3361
|
Classification Product Code |
|
Date Received | 09/19/2014 |
Decision Date | 03/27/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Clinical Trials |
NCT02098226
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|