The following data is part of a premarket notification filed by Clever Culture Systems Ag with the FDA for Apas Independence With Urine Analysis Module.
| Device ID | K183648 |
| 510k Number | K183648 |
| Device Name: | APAS Independence With Urine Analysis Module |
| Classification | Microbial Colony Image Assessment System |
| Applicant | Clever Culture Systems AG Seestrasse 204a Bach, CH Ch-8806 |
| Contact | Julie Winson |
| Correspondent | Julie Winson Clever Culture Systems AG Seestrasse 204a Bach, CH Ch-8806 |
| Product Code | PPU |
| CFR Regulation Number | 866.2190 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-26 |
| Decision Date | 2019-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 19354646000084 | K183648 | 000 |
| 09354646000001 | K183648 | 000 |