Device Classification Name |
colorimetry, acetaminophen
|
510(k) Number |
K822313 |
Device Name |
PROCEDURE #430 & REAGENTS FOR ACETAMIN |
Applicant |
SIGMA CHEMICAL CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
SIGMA CHEMICAL CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 862.3030
|
Classification Product Code |
|
Date Received | 08/03/1982 |
Decision Date | 08/24/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|