Device Classification Name |
Test, Qualitative And Quantitative Factor Deficiency
|
510(k) Number |
K193204 |
Device Name |
Cryocheck Chromogenic Factor VIII |
Applicant |
Precision BioLogic |
140 Eileen Stubbs Avenue |
Dartmouth,
CA
B3B 0A9
|
|
Applicant Contact |
Karen Black |
Correspondent |
Precision BioLogic |
140 Eileen Stubbs Avenue |
Dartmouth,
CA
B3B 0A9
|
|
Correspondent Contact |
Karen Black |
Regulation Number | 864.7290
|
Classification Product Code |
|
Date Received | 11/20/2019 |
Decision Date | 07/17/2020 |
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
|
|
|