Device Classification Name |
fibrinogen and fibrin split products, antigen, antiserum, control
|
510(k) Number |
K022977 |
Device Name |
STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C |
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 | 864.7320
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/06/2002 |
Decision Date | 11/27/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|