Device Classification Name |
Control, Hemoglobin
|
510(k) Number |
K070546 |
Device Name |
LYPHOCHEK DIABETES CONTROL |
Applicant |
Bio-Rad Laboratories |
9500 JERONIMO RD. |
IRVINE,
CA
92618 -2017
|
|
Applicant Contact |
ELIZABETH PLATT |
Correspondent |
Bio-Rad Laboratories |
9500 JERONIMO RD. |
IRVINE,
CA
92618 -2017
|
|
Correspondent Contact |
ELIZABETH PLATT |
Regulation Number | 864.8625
|
Classification Product Code |
|
Date Received | 02/26/2007 |
Decision Date | 04/02/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|