Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K081716
Device Classification Name
Hepatitis A Test (Antibody And Igm Antibody)
More FDA Info for this Device
510(K) Number
K081716
Device Name
Hepatitis A Test (Antibody And Igm Antibody)
Applicant
Siemens Healthcare Diagnostics Inc.
511 BENEDICT AVE.
TARRYTOWN, NY 10591 US
Other 510(k) Applications for this Company
Contact
MARY SEEGER
Other 510(k) Applications for this Contact
Regulation Number
866.3310
More FDA Info for this Regulation Number
Classification Product Code
LOL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/18/2008
Decision Date
07/17/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact