Device Classification Name |
nad reduction/nadh oxidation, cpk or isoenzymes
|
510(k) Number |
K081731 |
Device Name |
DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32 |
Applicant |
SIEMENS HEALTHCARE DIAGNOSTICS |
MS 514, PO BOX 6101 |
NEWARK,
DE
19714 -6101
|
|
Applicant Contact |
VICTOR M CARRIO |
Correspondent |
SIEMENS HEALTHCARE DIAGNOSTICS |
MS 514, PO BOX 6101 |
NEWARK,
DE
19714 -6101
|
|
Correspondent Contact |
VICTOR M CARRIO |
Regulation Number | 862.1215
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/19/2008 |
Decision Date | 08/29/2008 |
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
|
|
|