510(k) K183648
- Device
- APAS Independence With Urine Analysis Module
- Applicant
- Clever Culture Systems AG
- 510(k) number
- K183648
- Product code
- PPU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-05-15
- Date received
- 2018-12-26
- Regulation
- 866.2190
- Classification name
- Microbial Colony Image Assessment System
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Julie Winson
- Address
- Seestrasse 204a Bach CH CH-8806 CH-8806
FDA Registration Numbers#
- 3009288740
- 3023339158
- 3011637800
Source Documents#
Other 510(k) Records For Product Code PPU #
Legacy Summary#
summary
FDA Review#
Decision Summary