Device Classification Name |
Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms
|
510(k) Number |
K200839 |
Device Name |
APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module |
Applicant |
Clever Culture Systems |
Seestrasse 204a |
Bach,
CH
CH-8806
|
|
Applicant Contact |
Julie Winson |
Correspondent |
Clever Culture Systems |
Seestrasse 204a |
Bach,
CH
CH-8806
|
|
Correspondent Contact |
Julie Winson |
Regulation Number | 866.2190
|
Classification Product Code |
|
Date Received | 03/31/2020 |
Decision Date | 10/28/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|