510(k) K222996
- Device
- Access PCT
- Applicant
- Beckman Coulter, Inc.
- 510(k) number
- K222996
- Product code
- PTF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-04-26
- Date received
- 2022-09-28
- 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
- Neha Desai
- Address
- 1000 Lake Hazeltine Dr. Chaska MN US 55318 55318
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 |
|---|---|---|---|
| K242294 | DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls | Diasys Diagnostic Systems GmbH | 2025-05-09 |
| 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 |