510(k) K162297
- Device
- Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set
- Applicant
- Diazyme Laboratories
- 510(k) number
- K162297
- Product code
- PTF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-04-18
- Date received
- 2016-08-16
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Abhijit Datta
- Address
- 12889 Gregg Ct. Poway CA US 92130 92130
FDA Registration Numbers#
- 3008344661
- 3002809144
- 1181121
- 2032900
- 3005333358
- 2122870
- 3006644620
- 1616487
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PTF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242294 | DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls | Diasys Diagnostic Systems GmbH | 2025-05-09 |
| K222996 | Access PCT | Beckman Coulter, Inc. | 2023-04-26 |
| K192271 | Access PCT, Access PCT Calibrators | Beckman Coulter, Inc. | 2019-11-26 |
Legacy Summary#
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FDA Review#
Decision Summary