The following data is part of a premarket notification filed by Clever Culture Systems with the FDA for Apas Independence With Ic Chromogenic Mrsa Bd Analysis Module; Apas Independence With Ic Chromogenic Mrsa Tfs/s Analysis Module.
| Device ID | K200839 |
| 510k Number | K200839 |
| Device Name: | APAS Independence With IC Chromogenic MRSA BD Analysis Module; APAS Independence With IC Chromogenic MRSA TFS/S Analysis Module |
| Classification | Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms |
| Applicant | Clever Culture Systems Seestrasse 204a Bach, CH Ch-8806 |
| Contact | Julie Winson |
| Correspondent | Julie Winson Clever Culture Systems Seestrasse 204a Bach, CH Ch-8806 |
| Product Code | QQY |
| CFR Regulation Number | 866.2190 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-31 |
| Decision Date | 2021-10-28 |