Device Classification Name |
Calibrator, Multi-Analyte Mixture
|
510(k) Number |
K013178 |
Device Name |
DC-UIBC-CO2-CAL, MODEL SE-153 |
Applicant |
DIAGNOSTIC CHEMICALS LTD. |
16 MCCARVILLE ST. |
CHARLOTTETOWN,
CA
C1E 2A6
|
|
Applicant Contact |
NANCY OLSCAMP |
Correspondent |
DIAGNOSTIC CHEMICALS LTD. |
16 MCCARVILLE ST. |
CHARLOTTETOWN,
CA
C1E 2A6
|
|
Correspondent Contact |
NANCY OLSCAMP |
Regulation Number | 862.1150
|
Classification Product Code |
|
Date Received | 09/24/2001 |
Decision Date | 12/18/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|