Device Classification Name |
Urease And Glutamic Dehydrogenase, Urea Nitrogen
|
510(k) Number |
K073295 |
Device Name |
UREA/BUN, SCAL, NORTROL, ABTROL |
Applicant |
THERMO FISHER SCIENTIFIC OY |
2 RATASTIE |
VANTAA,
FI
01620
|
|
Applicant Contact |
PAIVI SORMUNEN |
Correspondent |
THERMO FISHER SCIENTIFIC OY |
2 RATASTIE |
VANTAA,
FI
01620
|
|
Correspondent Contact |
PAIVI SORMUNEN |
Regulation Number | 862.1770
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/23/2007 |
Decision Date | 05/29/2008 |
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
|
|
|