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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 5, 2025 | Beckman Coulter Inc. Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems Open, Classified |
PTF | K192271 |
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