Device Classification Name |
Colorimetry, Acetaminophen
|
510(k) Number |
K061655 |
Device Name |
DIMENSION VISTA FLEX REAGENT CARTRIDGES |
Applicant |
DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY |
BLDG.500 M.S. 514; PO BOX 6101 |
NEWARK,
DE
19714 -6101
|
|
Applicant Contact |
LORRAINE H PIESTRAK |
Correspondent |
DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY |
BLDG.500 M.S. 514; PO BOX 6101 |
NEWARK,
DE
19714 -6101
|
|
Correspondent Contact |
LORRAINE H PIESTRAK |
Regulation Number | 862.3030
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/13/2006 |
Decision Date | 07/10/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|