Device Classification Name |
Calibrator, Multi-Analyte Mixture
|
510(k) Number |
K041926 |
Device Name |
HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278 |
Applicant |
DIAGNOSTIC CHEMICALS LTD. |
16 MCCARVILLE ST. |
CHARLOTTETOWN, PE,
CA
C1E 2A6
|
|
Applicant Contact |
NANCY OLSCAMP |
Correspondent |
DIAGNOSTIC CHEMICALS LTD. |
16 MCCARVILLE ST. |
CHARLOTTETOWN, PE,
CA
C1E 2A6
|
|
Correspondent Contact |
NANCY OLSCAMP |
Regulation Number | 862.1150
|
Classification Product Code |
|
Date Received | 07/19/2004 |
Decision Date | 11/23/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|