Device Classification Name |
Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase
|
510(k) Number |
K860349 |
Device Name |
LACTATE DEHYDROGENASE (LDH) REAGENT SET |
Applicant |
STERLING DIAGNOSTICS, INC. |
34210 DEQUINDRE RD. |
STERLING HEIGHTS,
MI
48077
|
|
Applicant Contact |
DAVID L CALLENDER |
Correspondent |
STERLING DIAGNOSTICS, INC. |
34210 DEQUINDRE RD. |
STERLING HEIGHTS,
MI
48077
|
|
Correspondent Contact |
DAVID L CALLENDER |
Regulation Number | 862.1440
|
Classification Product Code |
|
Date Received | 01/30/1986 |
Decision Date | 02/28/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|