Device Classification Name |
System, Test, Blood Glucose, Over The Counter
|
510(k) Number |
K012210 |
Device Name |
MODIFICATION TO ACCU-CHEK INFORM METER |
Applicant |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. |
P.O. BOX 50416 |
INDIANAPOLIS,
IN
46250 -0457
|
|
Applicant Contact |
MIKE FLIS |
Correspondent |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. |
P.O. BOX 50416 |
INDIANAPOLIS,
IN
46250 -0457
|
|
Correspondent Contact |
MIKE FLIS |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/16/2001 |
Decision Date | 08/09/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|