Device Classification Name |
tetrazolium int dye-diaphorase, lactate dehydrogenase
|
510(k) Number |
K050790 |
Device Name |
SPOTCHEM II LDH TEST |
Applicant |
ARKRAY, INC. |
510 FURNACE DOCK RD. |
CORTLANDT MANOR,
NY
10567
|
|
Applicant Contact |
HELEN LANDICHO |
Correspondent |
ARKRAY, INC. |
510 FURNACE DOCK RD. |
CORTLANDT MANOR,
NY
10567
|
|
Correspondent Contact |
HELEN LANDICHO |
Regulation Number | 862.1440
|
Classification Product Code |
|
Date Received | 03/28/2005 |
Decision Date | 06/06/2005 |
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
|
|
|