Panels › Microbiology › Product code PTF · Class 2
Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission
Regulation 866.3215
0510(k)s in 12 months (4 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in PTF
| Company | 510(k)s | Recalls |
|---|---|---|
| Beckman Coulter, Inc. | 2 | 1 |
| Diasys Diagnostic Systems GmbH | 1 | 0 |
| Diazyme Laboratories | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 9, 2025 | K242294 | DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls Diasys Diagnostic Systems GmbH, DE | PTF |
| Apr 26, 2023 | K222996 | Access PCT Beckman Coulter, Inc. | PTF |
| Nov 26, 2019 | K192271 | Access PCT, Access PCT Calibrators Beckman Coulter, Inc. | PTF |
| Apr 18, 2017 | K162297 | Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set Diazyme Laboratories | PTF |
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