Device Classification Name |
counter, urine particle
|
510(k) Number |
K210127 |
Device Name |
iQ200 System, iChemVELOCITY Automated Urine Chemistry System |
Applicant |
Beckman Coulter, Inc. |
11800 SW 147th Ave |
Miami,
FL
33196
|
|
Applicant Contact |
Marisa Pugliese |
Correspondent |
Beckman Coulter, Inc. |
11800 SW 147th Ave |
Miami,
FL
33196
|
|
Correspondent Contact |
Marisa Pugliese |
Regulation Number | 864.5200
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/19/2021 |
Decision Date | 07/02/2021 |
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
|
|
|