Device Classification Name |
Multi-Analyte Controls, All Kinds (Assayed)
|
510(k) Number |
K023410 |
Device Name |
VALIDATE CHEM 10 CALIBRATION VERIFICATION TEST SET, MODEL 110 |
Applicant |
MAINE STANDARDS CO. |
765 ROOSEVELT TRAIL |
SUITE 9A |
WINDHAM,
ME
04062 -5365
|
|
Applicant Contact |
CHRISTINE BEACH |
Correspondent |
MAINE STANDARDS CO. |
765 ROOSEVELT TRAIL |
SUITE 9A |
WINDHAM,
ME
04062 -5365
|
|
Correspondent Contact |
CHRISTINE BEACH |
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 10/10/2002 |
Decision Date | 01/06/2003 |
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
|
|
|