Device Classification Name |
colorimetry, acetaminophen
|
510(k) Number |
K100200 |
Device Name |
ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138 |
Applicant |
SIEMENS HEALTHCARE DIAGNOSTICS |
511 benedict Avenue |
Tarrytown,
NY
10591
|
|
Applicant Contact |
KIRA GORDON |
Correspondent |
SIEMENS HEALTHCARE DIAGNOSTICS |
511 benedict Avenue |
Tarrytown,
NY
10591
|
|
Correspondent Contact |
KIRA GORDON |
Regulation Number | 862.3030
|
Classification Product Code |
|
Date Received | 01/25/2010 |
Decision Date | 08/02/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|