Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set
FDA 510(k) clearance K162297 · decided 2017-04-18
Clearance details
- K-number
- K162297
- Device name
- Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set
- Applicant
- Diazyme Laboratories
- Decision
- Substantially Equivalent
- Date received
- 2016-08-16
- Decision date
- 2017-04-18
- Days to decision
- 245 days
- Clearance type
- Traditional
- Product code
- PTF
- Device class
- 2
- Regulation number
- 866.3215
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Poway, CA, US
- 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 |
|---|---|---|
| DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls (K242294) | Diasys Diagnostic Systems GmbH | 2025-05-09 |
| Access PCT (K222996) | Beckman Coulter, Inc. | 2023-04-26 |
| Access PCT, Access PCT Calibrators (K192271) | Beckman Coulter, Inc. | 2019-11-26 |
Recalls involving this device
No recalls on record reference this clearance.