Device Classification Name |
multi-analyte controls, all kinds (assayed)
|
510(k) Number |
K134013 |
Device Name |
LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE CO |
Applicant |
Bio-Rad Laboratories |
9500 JERONIMO RD. |
IRVINE,
CA
92618 -2017
|
|
Applicant Contact |
SUZANNE PARSONS |
Correspondent |
Bio-Rad Laboratories |
9500 JERONIMO RD. |
IRVINE,
CA
92618 -2017
|
|
Correspondent Contact |
SUZANNE PARSONS |
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 12/30/2013 |
Decision Date | 04/24/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Immunology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|