Device Classification Name |
Diazo Colorimetry, Bilirubin
|
510(k) Number |
K093623 |
Device Name |
GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO |
Applicant |
INSTRUMENTATION LABORATORY CO. |
180 HARTWELL AVE. |
BEDFORD,
MA
01730
|
|
Applicant Contact |
CAROL MARBLE |
Correspondent |
INSTRUMENTATION LABORATORY CO. |
180 HARTWELL AVE. |
BEDFORD,
MA
01730
|
|
Correspondent Contact |
CAROL MARBLE |
Regulation Number | 862.1110
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/23/2009 |
Decision Date | 06/18/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|