Device Classification Name |
platelet factor 4 radioimmunoassay
|
510(k) Number |
K201570 |
Device Name |
PF4 Enhanced assay |
Applicant |
Immucor GTI Diagnostics, Inc. |
20925 Crossroads Circle |
Waukesha,
WI
53186
|
|
Applicant Contact |
Allison Stray |
Correspondent |
Immucor GTI Diagnostics, Inc. |
20925 Crossroads Circle |
Waukesha,
WI
53186
|
|
Correspondent Contact |
Allison Stray |
Regulation Number | 864.7695
|
Classification Product Code |
|
Date Received | 06/11/2020 |
Decision Date | 09/11/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|