Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K011337
Device Classification Name
System, Automated Platelet Aggregation
More FDA Info for this Device
510(K) Number
K011337
Device Name
System, Automated Platelet Aggregation
Applicant
ACCUMETRICS, INC.
3985 SORRENTO VALLEY BLVD.
SAN DIEGO, CA 92121 US
Other 510(k) Applications for this Company
Contact
RHONDA MOE
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
05/02/2001
Decision Date
10/16/2001
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