Device Classification Name |
Calibrator, Multi-Analyte Mixture
|
510(k) Number |
K011035 |
Device Name |
DIMENSION DRUG CALIBRATOR, MODEL DC22B |
Applicant |
DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY |
BLDG 500, MS 514 P.O.BOX 6101 |
NEWARK,
DE
19714 -6101
|
|
Applicant Contact |
RICHARD M VAUGHT |
Correspondent |
DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY |
BLDG 500, MS 514 P.O.BOX 6101 |
NEWARK,
DE
19714 -6101
|
|
Correspondent Contact |
RICHARD M VAUGHT |
Regulation Number | 862.1150
|
Classification Product Code |
|
Date Received | 04/05/2001 |
Decision Date | 06/14/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|