Device Classification Name |
tetrazolium int dye-diaphorase, lactate dehydrogenase
|
510(k) Number |
K895138 |
Device Name |
CLINISTAT LDH REAGENT TEST |
Applicant |
HERAEUS KULZER, INC. |
DIAGNOSTICS DIVISION |
P.O. BOX 70 |
ELKHART,
IN
46515
|
|
Applicant Contact |
ROSANNE SAVOL |
Correspondent |
HERAEUS KULZER, INC. |
DIAGNOSTICS DIVISION |
P.O. BOX 70 |
ELKHART,
IN
46515
|
|
Correspondent Contact |
ROSANNE SAVOL |
Regulation Number | 862.1440
|
Classification Product Code |
|
Date Received | 08/16/1989 |
Decision Date | 10/19/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|