510(k) K242294
- Device
- DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls
- Applicant
- Diasys Diagnostic Systems GmbH
- 510(k) number
- K242294
- Product code
- PTF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-05-09
- Date received
- 2024-08-02
- Regulation
- 866.3215
- Classification name
- Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jan Gorka
- Address
- Alte Strasse 9 Holzheim DE 65558 65558
FDA Registration Numbers#
- 3008344661
- 3002809144
- 1181121
- 2032900
- 3005333358
- 2122870
- 3006644620
- 1616487
Source Documents#
Other 510(k) Records For Product Code PTF#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K222996 | Access PCT | Beckman Coulter, Inc. | 2023-04-26 |
| K192271 | Access PCT, Access PCT Calibrators | Beckman Coulter, Inc. | 2019-11-26 |
| K162297 | Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set | Diazyme Laboratories | 2017-04-18 |