Device Classification Name |
Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase
|
510(k) Number |
K812836 |
Device Name |
LDH REAGENT SET |
Applicant |
ANCO MEDICAL REAGENTS & ASSOC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
ANCO MEDICAL REAGENTS & ASSOC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 862.1440
|
Classification Product Code |
|
Date Received | 10/09/1981 |
Decision Date | 10/09/1981 |
Decision |
SE - Postmarket Surveillance Required
(SESP) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|