Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K961062
Device Classification Name
Reagent, Occult Blood
More FDA Info for this Device
510(K) Number
K961062
Device Name
Reagent, Occult Blood
Applicant
SMITHKLINE DIAGNOSTICS, INC.
606 ELMWOOD AVE.
COURT III
SHARON HILL, PA 19079-1031 US
Other 510(k) Applications for this Company
Contact
MARSHALL C MCCARTY
Other 510(k) Applications for this Contact
Regulation Number
864.6550
More FDA Info for this Regulation Number
Classification Product Code
KHE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/18/1996
Decision Date
11/06/1996
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