Device Classification Name |
Enzymatic Esterase--Oxidase, Cholesterol
|
510(k) Number |
K880237 |
Device Name |
CHOLESTEROL |
Applicant |
TECH-NEAL SCIENTIFIC, INC. |
817 OAKWOOD DR. |
WESTMONT,
IL
60559
|
|
Applicant Contact |
ARUN SANGHAVI |
Correspondent |
TECH-NEAL SCIENTIFIC, INC. |
817 OAKWOOD DR. |
WESTMONT,
IL
60559
|
|
Correspondent Contact |
ARUN SANGHAVI |
Regulation Number | 862.1175
|
Classification Product Code |
|
Date Received | 01/20/1988 |
Decision Date | 04/28/1988 |
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
|
|
|