Device Classification Name |
System, Automated Platelet Aggregation
|
510(k) Number |
K013596 |
Device Name |
MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP) |
Applicant |
ACCUMETRICS, INC. |
3985 SORRENTO VALLEY BLVD. |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
RHONDA MOE |
Correspondent |
ACCUMETRICS, INC. |
3985 SORRENTO VALLEY BLVD. |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
RHONDA MOE |
Regulation Number | 864.5700
|
Classification Product Code |
|
Date Received | 10/31/2001 |
Decision Date | 05/16/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|