Device Classification Name |
Calibrator, Secondary
|
510(k) Number |
K020894 |
Device Name |
CALIBRATING MATERIAL, CAL-PAK, BUFFERS |
Applicant |
MISSION DIAGNOSTICS |
331 FISKE ST. |
HOLLISTON,
MA
01746
|
|
Applicant Contact |
LINDA STUNDTNER |
Correspondent |
MISSION DIAGNOSTICS |
331 FISKE ST. |
HOLLISTON,
MA
01746
|
|
Correspondent Contact |
LINDA STUNDTNER |
Regulation Number | 862.1150 |
Classification Product Code |
|
Date Received | 03/19/2002 |
Decision Date | 04/29/2002 |
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
|
Predetermined Change Control Plan Authorized |
No
|
|
|