Device Classification Name |
Glucose Oxidase, Glucose
|
510(k) Number |
K020935 |
Device Name |
HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706 |
Applicant |
HEMOCUE, INC. |
9229 CRANFORD DR. |
POTOMAC,
MD
20854
|
|
Applicant Contact |
R.J. SLOMOFF |
Correspondent |
HEMOCUE, INC. |
9229 CRANFORD DR. |
POTOMAC,
MD
20854
|
|
Correspondent Contact |
R.J. SLOMOFF |
Regulation Number | 862.1345
|
Classification Product Code |
|
Date Received | 03/22/2002 |
Decision Date | 04/03/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|