Device Classification Name |
system, multipurpose for in vitro coagulation studies
|
510(k) Number |
K183160 |
Device Name |
TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge |
Applicant |
Haemonetics Corporation |
400 Wood Road |
Braintree,
MA
02184
|
|
Applicant Contact |
Nancy Bengtson |
Correspondent |
Haemonetics Corporation |
400 Wood Road |
Braintree,
MA
02184
|
|
Correspondent Contact |
Mark Anzalone |
Regulation Number | 864.5425
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/15/2018 |
Decision Date | 05/09/2019 |
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
|
|
|