Device Classification Name |
Urease And Glutamic Dehydrogenase, Urea Nitrogen
|
510(k) Number |
K041051 |
Device Name |
RAICHEM BUN RATE REAGENT (LIQUID) |
Applicant |
HEMAGEN DIAGNOSTICS, INC. |
9033 RED BRANCH RD. |
COLUMBIA,
MD
21045
|
|
Applicant Contact |
JAMES J MILLER |
Correspondent |
HEMAGEN DIAGNOSTICS, INC. |
9033 RED BRANCH RD. |
COLUMBIA,
MD
21045
|
|
Correspondent Contact |
JAMES J MILLER |
Regulation Number | 862.1770
|
Classification Product Code |
|
Date Received | 04/19/2004 |
Decision Date | 06/30/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|