Device Classification Name |
multi-analyte controls, all kinds (assayed)
|
510(k) Number |
K093384 |
Device Name |
MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3) |
Applicant |
DIAMOND DIAGNOSTICS, INC. |
333 FISKE ST. |
HOLLISTON,
MA
01746
|
|
Applicant Contact |
KATHY CRUZ |
Correspondent |
DIAMOND DIAGNOSTICS, INC. |
333 FISKE ST. |
HOLLISTON,
MA
01746
|
|
Correspondent Contact |
KATHY CRUZ |
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 10/30/2009 |
Decision Date | 03/10/2010 |
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
|
Recalls |
CDRH Recalls
|
|
|