Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K961312
Device Classification Name
System, Hemoglobin, Automated
More FDA Info for this Device
510(K) Number
K961312
Device Name
System, Hemoglobin, Automated
Applicant
HEMOCUE, INC.
C/O ROBERT JOEL SLOMOF
9229 CRANFORD DRIVE
POTOMAC, MD 20854 US
Other 510(k) Applications for this Company
Contact
ROBERT J SLOMOF
Other 510(k) Applications for this Contact
Regulation Number
864.5620
More FDA Info for this Regulation Number
Classification Product Code
GKR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/04/1996
Decision Date
09/24/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact