Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K982802
Device Classification Name
Counter, Differential Cell
More FDA Info for this Device
510(K) Number
K982802
Device Name
Counter, Differential Cell
Applicant
BAYER CORP.
511 BENEDICT AVE.
TARRYTOWN, NY 10591-5097 US
Other 510(k) Applications for this Company
Contact
GABRIEL J MURACA
Other 510(k) Applications for this Contact
Regulation Number
864.5220
More FDA Info for this Regulation Number
Classification Product Code
GKZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/10/1998
Decision Date
09/22/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact