Device Classification Name |
analyzer, chemistry (photometric, discrete), for clinical use
|
510(k) Number |
K110035 |
Device Name |
INDIKO |
Applicant |
THERMO FISHER SCIENTIFIC OY |
RATASTIE 2 |
VANTAA,
FI
01620
|
|
Applicant Contact |
PAIVI SORMUNEN |
Correspondent |
THERMO FISHER SCIENTIFIC OY |
RATASTIE 2 |
VANTAA,
FI
01620
|
|
Correspondent Contact |
PAIVI SORMUNEN |
Regulation Number | 862.2160
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/05/2011 |
Decision Date | 06/28/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|