Device Classification Name |
method, enzymatic, glucose (urinary, non-quantitative)
|
510(k) Number |
K091216 |
Device Name |
CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797 |
Applicant |
SIEMENS HEALTHCARE DIAGNOSTICS |
2 EDGEWATER DRIVE |
NORWOOD,
MA
02062
|
|
Applicant Contact |
NOOR MALKI |
Correspondent |
SIEMENS HEALTHCARE DIAGNOSTICS |
2 EDGEWATER DRIVE |
NORWOOD,
MA
02062
|
|
Correspondent Contact |
NOOR MALKI |
Regulation Number | 862.1340
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/27/2009 |
Decision Date | 10/09/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|