Device Classification Name |
assay, heparin
|
510(k) Number |
K111822 |
Device Name |
STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH |
Applicant |
DIAGNOSTICA STAGO, INC. |
PIAZZA ALBANIA, 10 |
ROME,
IT
00153
|
|
Applicant Contact |
CARLO D'ALESSANDRO |
Correspondent |
DIAGNOSTICA STAGO, INC. |
PIAZZA ALBANIA, 10 |
ROME,
IT
00153
|
|
Correspondent Contact |
CARLO D'ALESSANDRO |
Regulation Number | 864.7525
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/28/2011 |
Decision Date | 10/26/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|