|
CLIA record K790282 and
corresponding 510(K) Premarket Notification
information
Test System
Name |
ELDONCARDS FOR BLOOD GROUPING
ABO AND RH(D) |
Document Number |
K790282 |
Analyte Name |
ABO Group - RBC |
Analyte Specialty |
Immunohematology |
Complexity |
MODERATE |
Effective Date |
07/27/2001 | | |
510(k) Premarket Notification Database
Device Classification Name |
system,
test, automated blood grouping and antibody |
510(k) Number |
K790282 |
Regulation Number |
864.9175 |
Device Name |
ELDONCARD |
Applicant |
|
Classification Product Code |
|
Date Received |
02/13/1979 |
Decision Date |
05/04/1979 |
Decision |
substantially equivalent (SE) |
Classification Advisory Committee |
Hematology |
Review Advisory Committee |
Hematology |
Statement/Summary/Purged Status |
Purged, no summary or statement |
Type |
Traditional
|
Reviewed by Third Party |
No
| | | |