Device Classification Name |
glucose oxidase, glucose
|
510(k) Number |
K011233 |
Device Name |
MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100 |
Applicant |
APEX BIOTECHNOLOGY CORP. |
5182 WEST 76TH ST. |
MINNEAPOLIS,
MN
55439
|
|
Applicant Contact |
BRUCE A MACFARLANE |
Correspondent |
APEX BIOTECHNOLOGY CORP. |
5182 WEST 76TH ST. |
MINNEAPOLIS,
MN
55439
|
|
Correspondent Contact |
BRUCE A MACFARLANE |
Regulation Number | 862.1345
|
Classification Product Code |
|
Date Received | 04/23/2001 |
Decision Date | 05/18/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|