DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls
FDA 510(k) clearance K242294 · decided 2025-05-09
Clearance details
- K-number
- K242294
- Device name
- DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls
- Applicant
- Diasys Diagnostic Systems GmbH
- Decision
- Substantially Equivalent
- Date received
- 2024-08-02
- Decision date
- 2025-05-09
- Days to decision
- 280 days
- Clearance type
- Traditional
- Product code
- PTF
- Device class
- 2
- Regulation number
- 866.3215
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Holzheim, DE
- 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 |
|---|---|---|
| Access PCT (K222996) | Beckman Coulter, Inc. | 2023-04-26 |
| Access PCT, Access PCT Calibrators (K192271) | Beckman Coulter, Inc. | 2019-11-26 |
| Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set (K162297) | Diazyme Laboratories | 2017-04-18 |
Recalls involving this device
No recalls on record reference this clearance.