Device Classification Name |
glucose dehydrogenase, glucose
|
510(k) Number |
K973662 |
Device Name |
ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS |
Applicant |
BOEHRINGER MANNHEIM CORP. |
9115 HAGUE RD. |
INDIANAPOLIS,
IN
46250 -0457
|
|
Applicant Contact |
MIKE FLIS |
Correspondent |
BOEHRINGER MANNHEIM CORP. |
9115 HAGUE RD. |
INDIANAPOLIS,
IN
46250 -0457
|
|
Correspondent Contact |
MIKE FLIS |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/25/1997 |
Decision Date | 12/15/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|