APAS Compact with Urine Analysis Module
FDA 510(k) clearance DEN150059 · decided 2016-10-06
Clearance details
- K-number
- DEN150059
- Device name
- APAS Compact with Urine Analysis Module
- Applicant
- Clever Culture Systems AG
- Decision
- Unknown
- Date received
- 2015-12-24
- Decision date
- 2016-10-06
- Days to decision
- 287 days
- Clearance type
- Direct
- Product code
- PPU
- Device class
- 2
- Regulation number
- 866.2190
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Baech, CH
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Clever Culture Systems AG
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PhenoMATRIX (K251511) | Copan Wasp Srl | 2026-01-22 |
| APAS Independence with Urine Analysis Module (K183648) | Clever Culture Systems AG | 2019-05-15 |
Recalls involving this device
No recalls on record reference this clearance.