Device Classification Name |
media and components, synthetic cell and tissue culture
|
510(k) Number |
K870490 |
Device Name |
(DME) W/1000 MG GLUCOSE/L NO. D4655 |
Applicant |
SIGMA CHEMICAL CO. |
P.O. BOX 14508 |
ST. LOUIS,
MO
63178
|
|
Applicant Contact |
DAVID BAGLEY |
Correspondent |
SIGMA CHEMICAL CO. |
P.O. BOX 14508 |
ST. LOUIS,
MO
63178
|
|
Correspondent Contact |
DAVID BAGLEY |
Regulation Number | 864.2220
|
Classification Product Code |
|
Date Received | 02/03/1987 |
Decision Date | 03/30/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Pathology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|