Device Classification Name |
Calibrator, Secondary
|
510(k) Number |
K121027 |
Device Name |
DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH |
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 | 862.1150
|
Classification Product Code |
|
Date Received | 04/04/2012 |
Decision Date | 12/20/2012 |
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
|
|
|