Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K971998
Device Classification Name
Counter, Cell, Automated (Particle Counter)
More FDA Info for this Device
510(K) Number
K971998
Device Name
Counter, Cell, Automated (Particle Counter)
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
864.5200
More FDA Info for this Regulation Number
Classification Product Code
GKL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/30/1997
Decision Date
08/29/1997
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