Device Classification Name |
Glucose Oxidase, Glucose
|
510(k) Number |
K000365 |
FOIA Releasable 510(k) |
K000365
|
Device Name |
ACCU-CHEK ADVANTAGE METER |
Applicant |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. |
P.O. BOX 50457 |
INDIANAPOLIS,
IN
46250 -0457
|
|
Applicant Contact |
MIKE FLIS |
Correspondent |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. |
P.O. BOX 50457 |
INDIANAPOLIS,
IN
46250 -0457
|
|
Correspondent Contact |
MIKE FLIS |
Regulation Number | 862.1345
|
Classification Product Code |
|
Date Received | 02/04/2000 |
Decision Date | 02/23/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|