Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K990398
Device Classification Name
System, Automated Platelet Aggregation
More FDA Info for this Device
510(K) Number
K990398
Device Name
System, Automated Platelet Aggregation
Applicant
ARRAY MEDICAL, INC.
ONE HARVARD WAY, SUITE 5
HILLSBOROUGH CAMPUS
SOMERVILLE, NJ 08876 US
Other 510(k) Applications for this Company
Contact
DAVID CARVILLE
Other 510(k) Applications for this Contact
Regulation Number
864.5700
More FDA Info for this Regulation Number
Classification Product Code
JOZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/09/1999
Decision Date
12/01/1999
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