Device Classification Name |
Hepatitis A Test (Antibody And Igm Antibody)
|
510(k) Number |
K092355 |
Device Name |
MONOLISA ANTI-HAV EIA |
Applicant |
BIO-RAD LABORATORIES, INC. |
6565 185TH AVE., N.E. |
REDMOND,
WA
98052
|
|
Applicant Contact |
LINDA STASWICK |
Correspondent |
BIO-RAD LABORATORIES, INC. |
6565 185TH AVE., N.E. |
REDMOND,
WA
98052
|
|
Correspondent Contact |
LINDA STASWICK |
Regulation Number | 866.3310
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/04/2009 |
Decision Date | 10/29/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|