Device Classification Name |
multi-analyte controls, all kinds (assayed)
|
510(k) Number |
K042324 |
Device Name |
LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5 |
Applicant |
BIO-RAD |
9500 JERONIMO RD. |
IRVINE,
CA
92618 -2017
|
|
Applicant Contact |
MARIA ZEBELLOS |
Correspondent |
BIO-RAD |
9500 JERONIMO RD. |
IRVINE,
CA
92618 -2017
|
|
Correspondent Contact |
MARIA ZEBELLOS |
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 08/27/2004 |
Decision Date | 10/07/2004 |
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
|
|
|