APAS Independence with Urine Analysis Module
FDA 510(k) clearance K183648 · decided 2019-05-15
Clearance details
- K-number
- K183648
- Device name
- APAS Independence with Urine Analysis Module
- Applicant
- Clever Culture Systems AG
- Decision
- Substantially Equivalent
- Date received
- 2018-12-26
- Decision date
- 2019-05-15
- Days to decision
- 140 days
- Clearance type
- Traditional
- Product code
- PPU
- Device class
- 2
- Regulation number
- 866.2190
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Bach, CH
- Third-party review
- No
- Expedited review
- No
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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 Compact with Urine Analysis Module (DEN150059) | Clever Culture Systems AG | 2016-10-06 |
Recalls involving this device
No recalls on record reference this clearance.