Device Classification Name |
system, test, human chorionic gonadotropin
|
510(k) Number |
K203227 |
Device Name |
Elecsys HCG STAT |
Applicant |
ROCHE DIAGNOSTICS |
9115 Hague Road |
PO Box 50416 |
Indianapolis,
IN
46250
|
|
Applicant Contact |
Adennis N. Cora |
Correspondent |
ROCHE DIAGNOSTICS |
9115 Hague Road |
PO Box 50416 |
Indianapolis,
IN
46250
|
|
Correspondent Contact |
Adennis N. Cora |
Regulation Number | 862.1155
|
Classification Product Code |
|
Date Received | 11/02/2020 |
Decision Date | 08/18/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|