Device Classification Name |
enzymatic esterase--oxidase, cholesterol
|
510(k) Number |
K842160 |
Device Name |
CHOLESTEROL ASSSAY KIT |
Applicant |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
4 NEWLAND CRESCENT |
CHARLOTTETOWN |
CANADA,
|
|
Correspondent |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
4 NEWLAND CRESCENT |
CHARLOTTETOWN |
CANADA,
|
|
Regulation Number | 862.1175
|
Classification Product Code |
|
Date Received | 05/30/1984 |
Decision Date | 08/17/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|