Data / Medical devices / Australia / Clever Culture Systems Limited
Clever Culture Systems Limited: FDA-registered device maker in Adelaide South Australia, Australia, 2 510(k) clearances
Clever Culture Systems Limited is registered with the FDA (registration 3023339158) in Adelaide South Australia, Australia. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 28, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3023339158
- Address
- 16 Anster St, Adelaide South Australia, Australia, 5000
- Owner or operator
- Clever Culture Systems (10085613)
- Roles
- Specification developer
- First device listed
- July 11, 2022
- Registered through
- 2026
- Brand names listed
- APAS Independence with MRSA Analysis Module, APAS Independence with Urine Analysis Module
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms | QQY | 2 | Specification developer | accessdata.fda.gov |
| Microbial Colony Image Assessment System | PPU | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 28, 2021 | K200839 | APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module | QQY | Substantially Equivalent | Clever Culture Systems | accessdata.fda.gov |
| May 15, 2019 | K183648 | APAS Independence with Urine Analysis Module | PPU | Substantially Equivalent | Clever Culture Systems AG | accessdata.fda.gov |
Compare with other makers
- All makers of Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms
- All makers of Microbial Colony Image Assessment System
Updated October 28, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.