510(k) DEN150059
- Device
- APAS Compact with Urine Analysis Module
- Applicant
- Clever Culture Systems AG
- 510(k) number
- DEN150059
- Product code
- PPU
- Decision
- Unknown (DENG)
- Decision date
- 2016-10-06
- Date received
- 2015-12-24
- Regulation
- 866.2190
- Classification name
- Microbial Colony Image Assessment System
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Lusia Guthrie
- Address
- Seestrasse 204a Baech CH 8806 8806
FDA Registration Numbers#
- 3009288740
- 3023339158
- 3011637800
Source Documents#
510(k) summary PDF not indicated by FDA