Device Classification Name |
calibrator, primary
|
510(k) Number |
K032697 |
Device Name |
DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414) |
Applicant |
DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY |
P.O. BOX 6101, BUILDING 500 |
NEWARK,
DE
19714
|
|
Applicant Contact |
LORRAINE H PIESTRAK |
Correspondent |
DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY |
P.O. BOX 6101, BUILDING 500 |
NEWARK,
DE
19714
|
|
Correspondent Contact |
LORRAINE H PIESTRAK |
Regulation Number | 862.1150
|
Classification Product Code |
|
Date Received | 09/02/2003 |
Decision Date | 11/07/2003 |
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
|
|
|