Device Classification Name |
Assay, Glycosylated Hemoglobin
|
510(k) Number |
K011852 |
Device Name |
DIMENSION HAIC ASSAY, MODEL DF105 |
Applicant |
DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY |
P.O. BOX 6101, BUILDING 500 |
NEWARK,
DE
19714
|
|
Applicant Contact |
Cathy Craft |
Correspondent |
DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY |
P.O. BOX 6101, BUILDING 500 |
NEWARK,
DE
19714
|
|
Correspondent Contact |
Cathy Craft |
Regulation Number | 864.7470
|
Classification Product Code |
|
Date Received | 06/12/2001 |
Decision Date | 11/15/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|