Device Classification Name |
Glucose Oxidase, Glucose
|
510(k) Number |
K952875 |
Device Name |
ACCU-CHEK ALPHA MONITOR & ACCU-CHEK GLUCOSE TEST STRIPS |
Applicant |
BOEHRINGER MANNHEIM CORP. |
9115 HAGUE RD. |
INDIANAPOLIS,
IN
46250 -0457
|
|
Applicant Contact |
MICHAEL FLIS |
Correspondent |
BOEHRINGER MANNHEIM CORP. |
9115 HAGUE RD. |
INDIANAPOLIS,
IN
46250 -0457
|
|
Correspondent Contact |
MICHAEL FLIS |
Regulation Number | 862.1345
|
Classification Product Code |
|
Date Received | 06/19/1995 |
Decision Date | 11/21/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|